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Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections

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ClinicalTrials.gov Identifier: NCT02045797
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : September 21, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Infections, Bacterial
Interventions Drug: GSK2140944 Lyophile
Drug: GSK2140944 Capsules
Enrollment 126
Recruitment Details This study was conducted at 13 centers in the United States from 24 March 2014 to 22 July 2015.
Pre-assignment Details A total of 126 participants were randomly assigned to study treatment (all randomized population). A total of 122 participants, who received study treatment, were included in the Modified Intent-to-Treat population (mITT) and safety populations. The mITT population is used in overall study numbers and demographic information.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description Participants received GSK2140944 750 milligrams (mg) intravenous (IV) every 12 hours (q12h; twice daily [BID]) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10. Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10. Participants received GSK21409447 1000 mg IV every 8 hours (q8h) three times a day (TID) on Day 1 and Day 2 . Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Period Title: Overall Study
Started 58 39 25
Completed 51 32 24
Not Completed 7 7 1
Reason Not Completed
Adverse Event             3             1             0
Lack of Efficacy             1             0             0
Lost to Follow-up             2             3             1
Physician Decision             0             1             0
Withdrawal by Subject             1             2             0
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h Total
Hide Arm/Group Description Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10. Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10. Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10. Total of all reporting groups
Overall Number of Baseline Participants 58 39 25 122
Hide Baseline Analysis Population Description
mITT population: those participants who received study treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 39 participants 25 participants 122 participants
44.3  (11.35) 44.6  (10.76) 45.8  (12.64) 44.7  (11.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 39 participants 25 participants 122 participants
Female
18
  31.0%
12
  30.8%
5
  20.0%
35
  28.7%
Male
40
  69.0%
27
  69.2%
20
  80.0%
87
  71.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 39 participants 25 participants 122 participants
American Indian or Alaska Native
1
   1.7%
1
   2.6%
0
   0.0%
2
   1.6%
Asian
0
   0.0%
0
   0.0%
1
   4.0%
1
   0.8%
Native Hawaiian or Other Pacific Islander
1
   1.7%
0
   0.0%
0
   0.0%
1
   0.8%
Black or African American
1
   1.7%
2
   5.1%
0
   0.0%
3
   2.5%
White
55
  94.8%
36
  92.3%
24
  96.0%
115
  94.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate
Hide Description Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (MITT) population consisted of all randomized participants who received at least one dose of study medication.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Measure Type: Count of Participants
Unit of Measure: Participants
Number Cured
48
  82.8%
28
  71.8%
23
  92.0%
Number Withdrawn
1
   1.7%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Clinical Response and Outcome at Early Efficacy Visit
Hide Description The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of >=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., <20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Success
48
  82.8%
28
  71.8%
23
  92.0%
Clinical Failure
7
  12.1%
7
  17.9%
2
   8.0%
Unable to Determine
3
   5.2%
4
  10.3%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18)
Hide Description The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of >=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., <20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Time Frame Day 12 to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Success
52
  89.7%
32
  82.1%
21
  84.0%
Clinical Failure
1
   1.7%
1
   2.6%
1
   4.0%
Unable to Determine
5
   8.6%
6
  15.4%
3
  12.0%
4.Secondary Outcome
Title Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)
Hide Description The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as no increase in the total surface area of the lesion (as calculated by digital imaging) compared to post therapy visit and no further administration of antibacterial therapy for the lesion under study. Clinical recurrence was defined as death of participant; increase in the area of the lesion compared to post therapy visit or administration of additional antibacterial therapy for the lesion under study before the efficacy endpoint assessment for participants who were a clinical success at post therapy visit. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Time Frame Day 21 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Success
50
  86.2%
28
  71.8%
20
  80.0%
Clinical Failure
1
   1.7%
1
   2.6%
1
   4.0%
Clinical Recurrence
2
   3.4%
1
   2.6%
1
   4.0%
Unable to Determine
5
   8.6%
9
  23.1%
3
  12.0%
5.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample
Hide Description The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA in lesion sample has been presented.
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT consisted of all randomized participants who received at least one dose of study medication and had a Gram-positive pathogens identified from their Baseline bacteriology lesion sample.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 37 28 11
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 0 2 0
Microbiological Success, Presumed Eradication 24 17 9
Microbiological Failure, Persistence 11 3 2
Microbiological Failure, Presumed Persistence 4 6 0
6.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample
Hide Description The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MRSA in lesion sample has been presented.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 28 20 5
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 0 2 0
Microbiological Success, Presumed Eradication 18 10 4
Microbiological Failure, Persistence 7 3 1
Microbiological Failure, Presumed Persistence 4 5 0
7.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample
Hide Description The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MSSA in lesion sample has been presented.
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 10 8 6
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Presumed Eradication 6 7 5
Microbiological Failure, Persistence 4 0 1
Microbiological Failure, Presumed Persistence 0 1 0
8.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Hide Description The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for other Gram-positive aerobic pathogens in lesion sample has been presented.
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 4 4 3
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 2 2 0
Microbiological Success, Presumed Eradication 0 1 3
Microbiological Failure, Presumed Persistence 1 1 0
Microbiological Failure, Unable to Determine 1 0 0
9.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Hide Description The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for all Gram-positive aerobic pathogens in lesion sample has been presented.
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 40 29 13
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 2 4 0
Microbiological Success, Presumed Eradication 24 18 12
Microbiological Failure, Persistence 11 3 2
Microbiological Failure, Presumed Persistence 5 7 0
Microbiological Failure, Unable to Determine 1 0 0
10.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
Hide Description The microbiological outcome was determined by comparing Baseline bacteriology blood culture, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA, MRSA and all Gram-positive aerobic pathogens in blood sample has been presented.
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Number of pathogens
SA, Microbiological Success, Eradication 2
MRSA, Microbiological Success, Eradication 2
Aerobic, Microbiological Success, Eradication 2
11.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained at post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA in lesion sample has been presented.
Time Frame Day 12 to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 37 28 11
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 3 1 0
Microbiological Success, Presumed Eradication 32 24 8
Microbiological Failure, Presumed Persistence 3 2 1
Microbiological Failure, Presumed Recurrence 1 1 2
12.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA in lesion sample has been presented.
Time Frame Day 12 to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 28 20 5
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 3 0 0
Microbiological Success, Presumed Eradication 22 17 4
Microbiological Failure, Presumed Persistence 3 2 0
Microbiological Failure, Presumed Recurrence 1 1 1
13.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA in lesion sample has been presented.
Time Frame Day 12 to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 10 8 6
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 0 1 0
Microbiological Success, Presumed Eradication 10 7 4
Microbiological Failure, Presumed Persistence 0 0 1
Microbiological Failure, Presumed Recurrence 0 0 1
14.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Time Frame Day 12 to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 4 4 3
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Presumed Eradication 3 3 2
Microbiological Failure, Presumed Persistence 0 1 0
Microbiological Failure, Presumed Recurrence 1 0 1
15.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Time Frame Day 12 to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 40 29 13
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 3 1 0
Microbiological Success, Presumed Eradication 35 27 10
Microbiological Failure, Presumed Persistence 3 3 1
Microbiological Failure, Presumed Recurrence 2 1 3
16.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Time Frame Day 12 to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Number of pathogens
SA, Microbiological Success, Presumed Eradication 2
MRSA, Microbiological Success,Presumed Eradication 2
Aerobic,MicrobiologicalSuccess,PresumedEradication 2
17.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA pathogen in lesion sample has been presented.
Time Frame Day 21 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 37 28 11
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 1 0 0
Microbiological Success, Presumed Eradication 33 21 8
Microbiological Failure, Presumed Recurrence 1 4 0
Microbiological Failure, Unable to Determine 4 3 3
18.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA pathogen in lesion sample has been presented.
Time Frame Day 21 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 28 20 5
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 1 0 0
Microbiological Success, Presumed Eradication 23 14 4
Microbiological Failure, Presumed Recurrence 1 3 0
Microbiological Failure, Unable to Determine 4 3 1
19.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA pathogen in lesion sample has been presented.
Time Frame Day 21 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 10 8 6
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Presumed Eradication 10 7 4
Microbiological Failure, Presumed Recurrence 0 1 0
Microbiological Failure, Unable to Determine 0 0 2
20.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for other Gram-positive aerobic pathogens in lesion sample has been presented.
Time Frame Day 21 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 4 4 3
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Presumed Eradication 3 2 2
Microbiological Failure, Presumed Recurrence 0 1 0
Microbiological Failure, Unable to Determine 1 1 1
21.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Hide Description Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for all Gram-positive aerobic pathogens in lesion sample has been presented.
Time Frame Day 21 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 40 29 13
Measure Type: Number
Unit of Measure: Number of pathogens
Microbiological Success, Eradication 1 0 0
Microbiological Success, Presumed Eradication 36 23 10
Microbiological Failure, Presumed Recurrence 1 5 0
Microbiological Failure, Unable to Determine 5 4 4
22.Secondary Outcome
Title Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
Hide Description Microbiological outcome was determined by comparing Baseline blood culture, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA, MRSA and all Gram-positive aerobic pathogens in lesion sample has been presented.
Time Frame Day 21 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Microbiological ITT population.
Arm/Group Title Gepotidacin 750 mg q12h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Number of pathogens
SA, Microbiological Success, Presumed Eradication 2
MRSA,Microbiological Success,Presumed Eradication 2
Aerobic,MicrobiologicalSuccess,PresumedEradication 2
23.Secondary Outcome
Title Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy
Hide Description Samples for assessment of PK parameter Cmax was done on at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.
Time Frame Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population consisted of all participants in the PK concentration population for whom valid and evaluable PK parameters were derived. Only those participants available at the indicated time points were analyzed.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 50 33 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
4590
(42.4%)
6059
(29.8%)
8848
(105.5%)
24.Secondary Outcome
Title PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy
Hide Description Samples for assessment of PK parameter Cmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.
Time Frame Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 51 33 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
2342
(84.7%)
4329
(67.8%)
3858
(94.1%)
25.Secondary Outcome
Title PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy
Hide Description Samples for assessment of PK parameter tmax was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.
Time Frame Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 50 33 24
Median (Full Range)
Unit of Measure: Hours
1.95
(0.00 to 3.05)
1.90
(0.90 to 3.00)
1.93
(0.00 to 3.00)
26.Secondary Outcome
Title PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy
Hide Description Samples for assessment of PK parameter tmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.
Time Frame Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 51 33 24
Median (Full Range)
Unit of Measure: Hours
3.00
(0.95 to 12.00)
2.92
(1.02 to 12.00)
2.98
(0.98 to 8.00)
27.Secondary Outcome
Title PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy
Hide Description Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on IV therapy has been presented.
Time Frame Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 54 36 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour nanograms per milliliter
AUClast Number Analyzed 50 participants 33 participants 24 participants
15992
(36.7%)
20904
(31.8%)
20851
(64.8%)
AUC0-tau Number Analyzed 49 participants 33 participants 22 participants
16159
(36.3%)
20815
(31.7%)
21499
(66.9%)
28.Secondary Outcome
Title PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy
Hide Description Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on oral dose therapy has been presented.
Time Frame Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 51 34 25
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour nanograms per milliliter
AUClast Number Analyzed 51 participants 33 participants 24 participants
11965
(101.7%)
19308
(98.8%)
15923
(117.4%)
AUC0-tau Number Analyzed 44 participants 28 participants 22 participants
14404
(78.2%)
24253
(65.4%)
19300
(77.9%)
29.Secondary Outcome
Title Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens
Hide Description Reduction in susceptibility was defined as a >=4-fold increase in minimum inhibitory concentration (MIC) or >=6 millimeter decrease in zone size between an isolate obtained at Baseline and the same pathogen at subsequent visits.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified MITT Population.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 40 29 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
30.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or all events of possible drug-induced liver injury with hyperbilirubinemia.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population comprised the same set of participants from MITT population and received at least one dose of study medication.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
41
  70.7%
25
  64.1%
18
  72.0%
Any SAEs
1
   1.7%
1
   2.6%
0
   0.0%
31.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description SBP and DBP was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
SBP, ON IV TREATMENT/DAY 1 Number Analyzed 58 participants 38 participants 25 participants
-2.9  (15.07) -1.7  (13.90) -2.4  (9.43)
SBP, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 25 participants
-4.8  (14.63) 0.3  (13.55) -1.9  (9.73)
SBP, ON IV TREATMENT/DAY 3 Number Analyzed 44 participants 25 participants 18 participants
-1.7  (14.57) 1.6  (11.25) -2.1  (13.88)
SBP, ON IV TREATMENT/DAY 4 Number Analyzed 17 participants 10 participants 2 participants
-3.2  (14.25) -1.2  (17.11) -22.0  (31.11)
SBP, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 7 participants 0 participants
-4.8  (17.90) -1.6  (31.01)
SBP, ON IV TREATMENT/DAY 6 Number Analyzed 10 participants 6 participants 0 participants
-8.0  (14.60) -2.7  (14.83)
SBP, ON IV TREATMENT/DAY 7 Number Analyzed 5 participants 4 participants 0 participants
-17.0  (16.57) 2.3  (32.39)
SBP, ON IV TREATMENT/DAY 8 Number Analyzed 3 participants 0 participants 0 participants
-10.3  (29.87)
SBP, ON IV TREATMENT/DAY 9 Number Analyzed 2 participants 0 participants 0 participants
12.0  (1.41)
SBP, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
6.0 [1]   (NA)
SBP, ORAL - FIRST DAY Number Analyzed 53 participants 34 participants 25 participants
1.6  (13.36) 2.3  (13.86) -3.7  (13.59)
SBP, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 23 participants
2.8  (9.14) 1.9  (10.55) -0.9  (17.91)
SBP, POST THERAPY DAY 12-18 Number Analyzed 53 participants 32 participants 22 participants
-0.1  (13.71) 4.5  (11.33) 4.1  (11.09)
SBP, FOLLOW UP DAY 21-28 Number Analyzed 54 participants 30 participants 23 participants
2.5  (12.87) 2.1  (12.24) 1.7  (15.60)
SBP, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-23.0 [1]   (NA)
DBP, ON IV TREATMENT/DAY 1 Number Analyzed 58 participants 38 participants 25 participants
-3.1  (10.28) -2.9  (10.97) -2.3  (9.21)
DBP, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 25 participants
-3.5  (10.84) -0.9  (9.26) -2.1  (9.77)
DBP, ON IV TREATMENT/DAY 3 Number Analyzed 44 participants 25 participants 18 participants
-4.5  (10.98) -0.9  (9.93) -3.5  (14.74)
DBP, ON IV TREATMENT/DAY 4 Number Analyzed 17 participants 10 participants 2 participants
-1.9  (12.19) 0.6  (11.19) -12.5  (30.41)
DBP, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 7 participants 0 participants
-0.9  (13.66) -2.0  (14.83)
DBP, ON IV TREATMENT/DAY 6 Number Analyzed 10 participants 6 participants 0 participants
-1.4  (11.75) -9.2  (15.38)
DBP, ON IV TREATMENT/DAY 7 Number Analyzed 5 participants 4 participants 0 participants
-1.6  (23.37) -13.8  (19.09)
DBP, ON IV TREATMENT/DAY 8 Number Analyzed 3 participants 0 participants 0 participants
-0.3  (18.50)
DBP, ON IV TREATMENT/DAY 9 Number Analyzed 2 participants 0 participants 0 participants
13.0  (21.21)
DBP, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
8.0 [1]   (NA)
DBP, ORAL - FIRST DAY Number Analyzed 53 participants 34 participants 25 participants
0.0  (11.26) -1.0  (8.44) -3.4  (12.84)
DBP, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 23 participants
-1.2  (9.12) 0.4  (8.13) 0.0  (11.13)
DBP, POST THERAPY DAY 12-18 Number Analyzed 53 participants 32 participants 22 participants
2.2  (9.18) 2.3  (8.00) 3.5  (12.23)
DBP, FOLLOW UP DAY 21-28 Number Analyzed 54 participants 30 participants 23 participants
2.3  (11.00) 0.0  (9.94) 1.2  (13.44)
DBP, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-5.0 [1]   (NA)
[1]
Only one participant was analyzed.
32.Secondary Outcome
Title Change From Baseline in Pulse Rate
Hide Description Pulse rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Beats per minute
ON IV TREATMENT/DAY 1 Number Analyzed 58 participants 38 participants 25 participants
-4.5  (11.38) -3.8  (10.66) -2.0  (10.39)
ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 25 participants
-6.3  (14.31) -1.2  (10.66) -5.2  (10.78)
ON IV TREATMENT/DAY 3 Number Analyzed 44 participants 25 participants 18 participants
-7.5  (14.08) -6.6  (10.28) -7.1  (12.62)
ON IV TREATMENT/DAY 4 Number Analyzed 17 participants 10 participants 2 participants
-11.3  (18.27) -5.5  (10.37) -7.0  (12.73)
ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 7 participants 0 participants
-15.1  (22.36) -9.9  (13.50)
ON IV TREATMENT/DAY 6 Number Analyzed 10 participants 6 participants 0 participants
-16.9  (21.60) -11.0  (10.22)
ON IV TREATMENT/DAY 7 Number Analyzed 5 participants 4 participants 0 participants
-28.4  (33.57) -18.0  (16.75)
ON IV TREATMENT/DAY 8 Number Analyzed 3 participants 0 participants 0 participants
-32.3  (15.63)
ON IV TREATMENT/DAY 9 Number Analyzed 2 participants 0 participants 0 participants
-45.5  (31.82)
ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
-68.0 [1]   (NA)
ORAL - FIRST DAY Number Analyzed 53 participants 34 participants 25 participants
-6.7  (15.43) -5.6  (13.47) -7.0  (11.45)
ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 23 participants
-1.6  (12.35) -1.8  (10.53) -5.7  (15.33)
POST THERAPY DAY 12-18 Number Analyzed 53 participants 32 participants 22 participants
-1.6  (15.02) 2.7  (13.38) -7.0  (16.34)
FOLLOW UP DAY 21-28 Number Analyzed 54 participants 30 participants 25 participants
-1.6  (13.59) -1.1  (10.09) -2.5  (17.10)
POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-15.0 [1]   (NA)
[1]
Only one participant was analyzed.
33.Secondary Outcome
Title Change From Baseline in Respiratory Rate
Hide Description Respiratory rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
ON IV TREATMENT/DAY 1 Number Analyzed 58 participants 38 participants 25 participants
-0.4  (2.66) -0.1  (1.64) 0.7  (2.90)
ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 25 participants
0.1  (2.28) -0.3  (2.37) -0.5  (1.73)
ON IV TREATMENT/DAY 3 Number Analyzed 44 participants 25 participants 18 participants
0.3  (2.80) -0.6  (1.58) -0.3  (2.17)
ON IV TREATMENT/DAY 4 Number Analyzed 17 participants 10 participants 2 participants
-0.1  (1.78) -1.0  (1.94) -1.0  (1.41)
ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 7 participants 0 participants
-0.4  (2.22) -0.7  (1.25)
ON IV TREATMENT/DAY 6 Number Analyzed 10 participants 6 participants 0 participants
-0.1  (2.33) -0.8  (1.47)
ON IV TREATMENT/DAY 7 Number Analyzed 5 participants 4 participants 0 participants
-1.2  (2.68) -1.0  (1.15)
ON IV TREATMENT/DAY 8 Number Analyzed 3 participants 0 participants 0 participants
-1.3  (4.16)
ON IV TREATMENT/DAY 9 Number Analyzed 2 participants 0 participants 0 participants
-4.0  (2.83)
ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
-6.0 [1]   (NA)
ORAL - FIRST DAY Number Analyzed 53 participants 34 participants 25 participants
0.4  (2.33) 0.3  (1.66) 0.2  (1.92)
ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 23 participants
-0.2  (2.39) -0.1  (2.35) -0.2  (2.04)
POST THERAPY DAY 12-18 Number Analyzed 53 participants 32 participants 22 participants
0.0  (2.94) -0.3  (1.97) -0.4  (2.02)
FOLLOW UP DAY 21-28 Number Analyzed 54 participants 30 participants 23 participants
-0.6  (2.81) -0.3  (2.04) -0.5  (1.78)
POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-2.0 [1]   (NA)
[1]
Only one participant was analyzed.
34.Secondary Outcome
Title Change From Baseline in Vital Sign: Body Temperature
Hide Description Body temperature was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Celcius
ON IV TREATMENT/DAY 1 Number Analyzed 58 participants 38 participants 25 participants
-0.126  (0.6632) -0.053  (0.4114) -0.172  (0.4208)
ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 25 participants
-0.195  (0.6058) -0.173  (0.4642) -0.400  (0.5672)
ON IV TREATMENT/DAY 3 Number Analyzed 44 participants 25 participants 18 participants
-0.393  (0.5986) -0.308  (0.4216) -0.456  (0.7548)
ON IV TREATMENT/DAY 4 Number Analyzed 17 participants 10 participants 2 participants
-0.476  (0.7242) -0.455  (0.5610) -0.550  (0.2121)
ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 7 participants 0 participants
-0.662  (0.8412) -0.521  (0.6013)
ON IV TREATMENT/DAY 6 Number Analyzed 10 participants 6 participants 0 participants
-1.080  (0.9589) -0.842  (1.0670)
ON IV TREATMENT/DAY 7 Number Analyzed 5 participants 4 participants 0 participants
-1.400  (1.1726) -0.738  (0.8901)
ON IV TREATMENT/DAY 8 Number Analyzed 3 participants 0 participants 0 participants
-0.533  (0.6110)
ON IV TREATMENT/DAY 9 Number Analyzed 2 participants 0 participants 0 participants
-0.800  (0.7071)
ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
-1.100 [1]   (NA)
ORAL - FIRST DAY Number Analyzed 53 participants 34 participants 25 participants
-0.398  (0.8149) -0.304  (0.7005) -0.608  (0.7593)
ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 23 participants
-0.498  (0.6496) -0.468  (0.6417) -0.635  (0.8483)
POST THERAPY DAY 12-18 Number Analyzed 53 participants 32 participants 22 participants
-0.485  (0.7579) -0.439  (0.6764) -0.645  (0.9379)
FOLLOW UP DAY 21-28 Number Analyzed 54 participants 30 participants 23 participants
-0.441  (0.7579) -0.375  (0.7255) -0.604  (0.8891)
POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-0.200 [1]   (NA)
[1]
Only one participant was analyzed.
35.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
Hide Description The 12-lead ECGs was obtained at Day 1, Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for corrected QT, using Fridericia formula (QTcF), corrected QT using Bazett’s formula (QTcB) and QRS intervals. The number of participants with maximum post-baseline ECG value exceeding the following limits have been reported: QTcB/QTcF interval > 450 and ≤ 480 millisecond (msec), QTcB/QTcF interval > 480 and ≤ 500 msec, QTcB/QTcF interval > 500 msec, QRS interval < 70 msec and QRS interval > 120 msec.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 38 25
Measure Type: Count of Participants
Unit of Measure: Participants
QTcB, Maximum Post-Baseline, <=450
27
  46.6%
15
  39.5%
9
  36.0%
QTcB, Maximum Post-Baseline, <=450 and <=480
28
  48.3%
19
  50.0%
11
  44.0%
QTcB, Maximum Post-Baseline, >480 and <=500
3
   5.2%
4
  10.5%
3
  12.0%
QTcB, Maximum Post-Baseline, >500
0
   0.0%
0
   0.0%
2
   8.0%
QTcF, Maximum Post-Baseline, <=450
47
  81.0%
28
  73.7%
17
  68.0%
QTcF, Maximum Post-Baseline, <=450 and <=480
11
  19.0%
10
  26.3%
8
  32.0%
QRS, Maximum Post-Baseline, 70 - 120
56
  96.6%
36
  94.7%
23
  92.0%
QRS, Maximum Post-Baseline, >120
2
   3.4%
2
   5.3%
2
   8.0%
36.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
Hide Description Blood samples for assessment of clinical chemistry parameters of ALT, ALP, AST, FSH and GGT was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: International units per liter
ALT, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-1.9  (5.40) -1.0  (4.67) 2.3  (14.57)
ALT, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
1.2  (14.63) 1.4  (9.71) 1.2  (6.30)
ALT, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
14.0 [1]   (NA)
ALT, ON IV TREATMENT/DAY 5 Number Analyzed 2 participants 6 participants 0 participants
9.3  (18.27) 2.8  (9.89)
ALT, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
37.5  (19.09) 18.5  (9.19)
ALT, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
ALT, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
3.6  (17.52) 4.1  (11.58) 5.7  (11.57)
ALT, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
6.6  (15.75) 7.3  (17.74) 6.3  (12.60)
ALT, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
12.8  (35.54) 8.3  (21.90) 4.2  (16.02)
ALT, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 5 participants 3 participants
36.2  (53.78) 27.8  (39.03) 9.3  (4.62)
ALT, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
22.0 [1]   (NA)
ALP, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-1.4  (11.52) -1.3  (12.27) -4.0  (12.23)
ALP, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
1.8  (18.97) 5.7  (14.17) -0.4  (6.17)
ALP, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
15.0 [1]   (NA)
ALP, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-0.3  (13.01) 5.0  (11.49)
ALP, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
3.0  (22.63) 10.0  (21.21)
ALP, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
ALP, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
5.1  (19.30) 4.0  (17.38) -0.4  (11.32)
ALP, ORAL - DAY 7-10 Number Analyzed 44 participants 30 participants 21 participants
3.8  (13.21) 2.2  (19.16) -0.1  (11.17)
ALP, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
-0.8  (15.97) 0.1  (16.16) -1.8  (11.72)
ALP, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 5 participants 3 participants
4.6  (19.49) 15.6  (20.84) -2.0  (3.61)
ALP, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
17.0 [1]   (NA)
AST, ON IV TREATMENT/DAY 2 Number Analyzed 55 participants 35 participants 24 participants
-1.1  (6.58) 0.7  (7.03) 2.0  (10.85)
AST, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
1.6  (12.47) 6.2  (22.30) 6.9  (18.84)
AST, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
22.0 [1]   (NA)
AST, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
7.4  (17.95) 4.2  (13.01)
AST, ON IV TREATMENT/DAY 7 Number Analyzed 1 participants 2 participants 0 participants
23.0 [1]   (NA) 22.0  (0.00)
AST, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
AST, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
4.3  (13.34) 34  (13.52) 6.3  (17.83)
AST, ORAL - DAY 7-10 Number Analyzed 44 participants 30 participants 21 participants
6.7  (12.08) 6.8  (13.93) 2.3  (17.44)
AST, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
10.9  (18.98) 9.0  (15.53) 0.8  (19.05)
AST, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 5 participants 3 participants
16.2  (22.15) 22.6  (29.90) 5.3  (2.52)
AST, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
9.0 [1]   (NA)
GGT, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-1.5  (7.68) -1.9  (8.10) -1.4  (10.15)
GGT, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
1.7  (18.66) 3.8  (12.23) 1.9  (5.16)
GGT, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-4.0 [1]   (NA)
GGT, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
3.3  (21.70) -2.5  (5.21)
GGT, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
25.5  (0.71) -3.0  (12.73)
GGT, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
GGT, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
3.3  (20.16) 4.5  (16.25) -1.1  (10.95)
GGT, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
3.6  (17.06) 7.5  (19.89) -2.2  (14.75)
GGT, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
3.0  (15.60) 5.3  (21.08) -3.9  (16.80)
GGT, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
6.0  (13.56) 64.0  (89.91) 3.0 [1]   (NA)
GGT, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
39.0 [1]   (NA)
[1]
Only one participant was analyzed.
37.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Hide Description Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Gram per liter
Albumin, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-2.4  (3.57) -1.1  (2.93) -2.9  (3.34)
Albumin, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
-1.7  (4.09) -0.6  (3.52) -2.0  (3.46)
Albumin, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
1.0 [1]   (NA)
Albumin, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-1.1  (4.09) -1.5  (3.62)
Albumin, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
4.0  (8.49) -0.5  (0.71)
Albumin, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Albumin, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
0.0  (3.39) -0.2  (3.37) -0.9  (2.86)
Albumin, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
1.8  (3.58) 1.4  (3.04) 1.2  (2.51)
Albumin, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
2.1  (3.81) 2.8  (4.41) 0.8  (3.61)
Albumin, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
2.8  (2.36) 0.3  (2.22) 0.0 [1]   (NA)
Albumin, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-4.0 [1]   (NA)
Protein, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-3.2  (6.36) -1.9  (5.86) -5.2  (6.28)
Protein, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
-1.6  (7.04) -0.3  (5.88) -4.8  (6.59)
Protein, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
0.0 [1]   (NA)
Protein, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-0.5  (8.22) -2.3  (7.34)
Protein, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
5.5  (13.44) -1.0  (8.49)
Protein, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Protein, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
1.4  (5.96) -0.2  (6.82) -1.2  (5.05)
Protein, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
3.1  (6.95) 2.2  (5.88) 0.5  (3.59)
Protein, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
2.9  (7.21) 3.1  (9.14) -1.1  (5.93)
Protein, FOLLOW UP DAY 21-28 Number Analyzed 58 participants 4 participants 1 participants
5.0  (5.29) 0.8  (5.06) -7.0 [1]   (NA)
Protein, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-3.0 [1]   (NA)
[1]
Only one participant was analyzed.
38.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Hide Description Blood samples for assessment of clinical chemistry parameters of bilirubin, creatinine, direct bilirubin and urate was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Bilirubin, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-1.9  (3.22) -1.3  (2.87) -2.4  (3.34)
Bilirubin, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
-2.8  (4.42) -1.0  (3.61) -2.2  (2.73)
Bilirubin, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-4.0 [1]   (NA)
Bilirubin, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-2.8  (4.64) -4.0  (2.53)
Bilirubin, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
0.0  (0.0) -4.0  (0.00)
Bilirubin, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Bilirubin, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
-1.9  (3.87) -1.7  (3.12) -2.4  (2.69)
Bilirubin, ORAL - DAY 7-10 Number Analyzed 44 participants 30 participants 21 participants
-0.9  (4.17) -0.7  (2.49) -1.7  (2.55)
Bilirubin, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
-1.0  (4.35) -0.5  (3.25) -1.4  (3.83)
Bilirubin, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 5 participants 3 participants
0.0  (8.72) 0.0  (4.69) -1.3  (6.11)
Bilirubin, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-2.0 [1]   (NA)
Creatinine, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
3.45  (11.885) -2.33  (19.886) 0.66  (8.711)
Creatinine, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
1.30  (10.462) -5.35  (28.787) -3.93  (12.123)
Creatinine, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-1.70 [1]   (NA)
Creatinine, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-0.91  (10.541) 7.37  (8.704)
Creatinine, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
8.40  (10.607) 6.65  (8.132)
Creatinine, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Creatinine, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
4.22  (11.115) -3.78  (27.598) 2.37  (10.268)
Creatinine, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
4.65  (9.930) 0.72  (30.659) 4.13  (9.518)
Creatinine, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
3.82  (10.641) 2.93  (26.419) 2.08  (9.293)
Creatinine, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
9.92  (12.289) -1.80  (2.846) 2.70 [1]   (NA)
Creatinine, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-2.70 [1]   (NA)
Direct Bilirubin, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-0.3  (2.09) -0.6  (1.79) -1.1  (2.28)
Direct Bilirubin, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
-0.2  (2.33) -0.7  (1.83) -1.3  (2.24)
Direct Bilirubin, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-2.0 [1]   (NA)
Direct Bilirubin, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-1.0  (1.94) -0.7  (2.73)
Direct Bilirubin, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
-1.0  (1.41) -3.0  (1.41)
Direct Bilirubin, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Direct Bilirubin, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
-0.4  (2.15) -0.2  (2.19) -1.0  (2.08)
Direct Bilirubin, ORAL - DAY 7-10 Number Analyzed 44 participants 30 participants 21 participants
0.0  (1.95) 0.0  (2.10) -1.0  (2.16)
Direct Bilirubin, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
-0.3  (2.02) 0.0  (1.68) -1.2  (2.03)
Direct Bilirubin, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
1.5  (5.00) 0.5  (1.91) 0.0 [1]   (NA)
Direct Bilirubin, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
0.0 [1]   (NA)
Urate, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
1.2  (44.16) -11.7  (42.46) -17.1  (50.43)
Urate, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
4.2  (66.33) 5.7  (52.02) -14.4  (97.10)
Urate, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
60.0 [1]   (NA)
Urate, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
26.0  (89.47) 46.7  (50.86)
Urate, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
10.0  (169.71) 90.0  (28.28)
Urate, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Urate, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
16.3  (52.46) 2.9  (67.26) -1.3  (67.71)
Urate, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
51.6  (55.31) 67.0  (69.79) 55.2  (65.32)
Urate, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
60.8  (73.88) 49.4  (83.24) 45.3  (60.31)
Urate, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
7.5  (80.16) 10.0  (102.31) 140.0 [1]   (NA)
Urate, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
70.0 [1]   (NA)
[1]
Only one participant was analyzed.
39.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Hide Description Blood samples for assessment of clinical chemistry parameters of calcium, carbon dioxide, chloride, glucose, magnesium, potassium, sodium and urea was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Millimole per liter
Calcium, ON IV TREATMENT/DAY 2 Number Analyzed 55 participants 35 participants 24 participants
-0.041  (0.1095) -0.018  (0.1227) -0.048  (0.1221)
Calcium, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
-0.007  (0.1732) 0.019  (0.1247) -0.009  (0.1289)
Calcium, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-0.180 [1]   (NA)
Calcium, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
0.024  (0.1313) -0.007  (0.1440)
Calcium, ON IV TREATMENT/DAY 7 Number Analyzed 1 participants 2 participants 0 participants
0.080 [1]   (NA) 0.040  (0.2263)
Calcium, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Calcium, ORAL - FIRST DAY Number Analyzed 50 participants 34 participants 23 participants
0.042  (0.1152) 0.022  (0.1245) 0.018  (0.0908)
Calcium, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
0.093  (0.1373) 0.064  (0.1063) 0.030  (0.1231)
Calcium, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
0.083  (0.1440) 0.087  (0.1363) 0.047  (0.1239)
Calcium, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 39 participants 1 participants
0.090  (0.1685) 0.060  (0.0673) 0.060 [1]   (NA)
Calcium, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-0.040 [1]   (NA)
Carbon Dioxide, ON IV TREATMENT/DAY 2 Number Analyzed 55 participants 35 participants 24 participants
-0.5  (2.87) -0.3  (2.46) 0.1  (2.49)
Carbon Dioxide, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
-0.5  (3.34) -0.6  (2.71) 0.4  (2.19)
Carbon Dioxide, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
1.0 [1]   (NA)
Carbon Dioxide, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
0.1  (4.28) 0.7  (3.39)
Carbon Dioxide, ON IV TREATMENT/DAY 7 Number Analyzed 1 participants 2 participants 0 participants
6.0 [1]   (NA) 2.5  (2.12)
Carbon Dioxide, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Carbon Dioxide, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
-0.5  (3.14) 0.1  (2.55) -0.4  (2.97)
Carbon Dioxide, ORAL - DAY 7-10 Number Analyzed 44 participants 30 participants 21 participants
-0.5  (2.43) 0.4  (2.87) -0.2  (3.09)
Carbon Dioxide, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
-0.3  (2.83) -0.1  (3.32) 1.0  (1.73)
Carbon Dioxide, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
-1.5  (3.32) 2.3  (1.89) 1.0 [1]   (NA)
Carbon Dioxide, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-4.0 [1]   (NA)
Chloride, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
2.1  (2.32) 1.3  (2.92) 2.4  (2.98)
Chloride, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
2.3  (2.92) 1.4  (2.78) 2.1  (4.04)
Chloride, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-1.0 [1]   (NA)
Chloride, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
2.9  (2.73) 0.5  (1.05)
Chloride, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
-0.5  (0.71) 0.5  (0.71)
Chloride, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Chloride, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
1.4  (2.52) 0.4  (2.70) 1.1  (3.13)
Chloride, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
0.8  (3.63) 0.7  (2.23) 1.2  (2.93)
Chloride, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 25 participants
1.7  (2.75) 1.6  (3.21) 1.8  (2.95)
Chloride, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
0.5  (4.93) -3.0  (2.94) 3.0 [1]   (NA)
Chloride, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
4.0 [1]   (NA)
Glucose, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
0.32  (1.973) -0.31  (2.863) -0.88  (2.462)
Glucose, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
0.40  (2.144) 0.48  (3.087) -0.37  (2.384)
Glucose, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
6.60 [1]   (NA)
Glucose, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-0.51  (3.257) 1.92  (1.723)
Glucose, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
-2.65  (4.313) 3.70  (2.687)
Glucose, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Glucose, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
0.11  (2.115) 0.13  (2.926) -0.04  (1.619)
Glucose, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
0.14  (1.698) 1.08  (3.066) -0.46  (1.741)
Glucose, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
-0.19  (1.774) 0.34  (2.719) -0.84  (2.068)
Glucose, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
-0.38  (1.284) 1.95  (3.450) -0.10 [1]   (NA)
Glucose, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
0.30 [1]   (NA)
Magnesium, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-0.013  (0.0682) -0.017  (0.0688) 0.004  (0.0865)
Magnesium, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
0.007  (0.0829) -0.012  (0.0553) 0.018  (0.0689)
Magnesium, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
0.000 [1]   (NA)
Magnesium, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
0.044  (0.0532) -0.040  (0.0738)
Magnesium, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
0.140  (0.0000) -0.080  (0.0283)
Magnesium, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Magnesium, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
-0.009  (0.0709) -0.016  (0.0592) 0.006  (0.0613)
Magnesium, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
0.006  (0.0810) -0.007  (0.0708) 0.021  (0.0659)
Magnesium, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
-0.005  (0.0864) 0.006  (0.0870) -0.008  (0.0737)
Magnesium, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
0.000  (0.1347) -0.040  (0.0283) 0.000 [1]   (NA)
Magnesium, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-0.040 [1]   (NA)
Potassium, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 35 participants 24 participants
0.15  (0.398) 0.07  (0.481) 0.22  (0.458)
Potassium, ON IV TREATMENT/DAY 3 Number Analyzed 32 participants 21 participants 9 participants
0.24  (0.353) 0.11  (0.429) 0.16  (0.433)
Potassium, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-0.10 [1]   (NA)
Potassium, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
0.28  (0.559) 0.02  (0.183)
Potassium, ON IV TREATMENT/DAY 7 Number Analyzed 0 participants 2 participants 0 participants
0.55  (0.495)
Potassium, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Potassium, ORAL - FIRST DAY Number Analyzed 50 participants 34 participants 23 participants
0.36  (0.374) 0.20  (0.468) 0.27  (0.365)
Potassium, ORAL - DAY 7-10 Number Analyzed 44 participants 30 participants 21 participants
0.29  (0.483) 0.06  (0.434) 0.05  (0.533)
Potassium, POST THERAPY DAY 12-18 Number Analyzed 51 participants 32 participants 19 participants
0.28  (0.543) 0.06  (0.573) 0.22  (0.487)
Potassium, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
1.03  (0.877) -0.35  (0.998) 0.60 [1]   (NA)
Potassium, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-0.10 [1]   (NA)
Sodium, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
1.1  (2.34) 0.9  (2.67) 1.6  (1.93)
Sodium, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
1.2  (2.59) 1.0  (2.65) 1.4  (4.16)
Sodium, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-3.0 [1]   (NA)
Sodium, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
2.8  (2.78) 1.0  (2.90)
Sodium, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
2.0  (2.83) 0.0  (8.49)
Sodium, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Sodium, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
1.2  (2.55) 0.3  (3.05) 1.2  (2.54)
Sodium, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
0.8  (2.44) 0.5  (2.90) 1.3  (2.55)
Sodium, POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
1.1  (2.53) 1.4  (2.70) 1.8  (2.93)
Sodium, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
-3.0  (2.71) -2.3  (2.87) 1.0 [1]   (NA)
Sodium, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
5.0 [1]   (NA)
Urea, ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-0.11  (1.308) -0.11  (1.189) -0.58  (1.110)
Urea, ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
-0.12  (1.484) -0.24  (1.715) -0.61  (2.088)
Urea, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-1.00 [1]   (NA)
Urea, ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-0.50  (1.414) 0.42  (1.320)
Urea, ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
1.00  (2.121) -0.25  (1.061)
Urea, ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
Urea, ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
-0.13  (1.360) -0.56  (1.650) -0.41  (1.379)
Urea, ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
0.77  (1.576) 0.10  (1.945) 0.29  (1.586)
Urea, POST THERAPY DAY 12-18 Number Analyzed 51 participants 32 participants 19 participants
0.60  (1.563) 0.63  (1.437) -0.03  (1.486)
Urea, FOLLOW UP DAY 21-28 Number Analyzed 4 participants 4 participants 1 participants
1.63  (2.016) 0.25  (1.041) -1.00 [1]   (NA)
Urea, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
0.00 [1]   (NA)
[1]
Only one participant was analyzed.
40.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
Hide Description Blood samples for assessment of clinical chemistry parameter of estimated creatinine clearance was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Milliliter per minute
ON IV TREATMENT/DAY 2 Number Analyzed 57 participants 35 participants 24 participants
-6.8  (22.65) -1.8  (17.47) -1.7  (17.98)
ON IV TREATMENT/DAY 3 Number Analyzed 33 participants 21 participants 9 participants
-4.8  (32.17) 1.7  (30.02) 3.8  (19.70)
ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
5.0 [1]   (NA)
ON IV TREATMENT/DAY 5 Number Analyzed 10 participants 6 participants 0 participants
-17.4  (59.39) -14.5  (14.92)
ON IV TREATMENT/DAY 7 Number Analyzed 2 participants 2 participants 0 participants
-22.0  (29.70) -9.5  (13.44)
ON IV TREATMENT/DAY 10 Number Analyzed 0 participants 0 participants 0 participants
ORAL - FIRST DAY Number Analyzed 51 participants 34 participants 23 participants
-12.6  (32.53) -1.1  (31.43) -6.3  (16.45)
ORAL - DAY 7-10 Number Analyzed 45 participants 30 participants 21 participants
-13.2  (29.04) -9.7  (36.67) -8.3  (16.53)
POST THERAPY DAY 12-18 Number Analyzed 52 participants 32 participants 19 participants
-8.8  (28.55) -10.4  (24.61) -5.6  (12.72)
FOLLOW UP DAY 21-28 Number Analyzed 3 participants 4 participants 0 participants
-13.7  (25.54) 3.8  (5.74)
POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
6.0 [1]   (NA)
[1]
Only one participant was analyzed.
41.Secondary Outcome
Title Estradiol Values at Baseline
Hide Description Blood samples for assessment of clinical chemistry parameter of estradiol was collected at Baseline (Day 1). No post-baseline values were reported.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 10 4 2
Mean (Standard Deviation)
Unit of Measure: Picomole per liter
229.4  (196.66) 148.8  (153.58) 23.5  (23.33)
42.Secondary Outcome
Title Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Hide Description Blood samples for assessment of hematology parameters of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Giga cells per liter
Basophils, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 30 participants 23 participants
0.000  (0.0330) 0.003  (0.0220) 0.007  (0.0216)
Basophils, ON IV TREATMENT/DAY 3 Number Analyzed 29 participants 21 participants 9 participants
-0.003  (0.0262) 0.003  (0.0217) -0.014  (0.0305)
Basophils, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-0.020 [1]   (NA)
Basophils, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 6 participants 0 participants
0.008  (0.0212) 0.007  (0.0437)
Basophils, ON IV TREATMENT/DAY 7 Number Analyzed 4 participants 1 participants 0 participants
0.013  (0.0206) 0.000 [1]   (NA)
Basophils, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
-0.020 [1]   (NA)
Basophils, ORAL - FIRST DAY Number Analyzed 48 participants 31 participants 22 participants
0.000  (0.0310) 0.000  (0.0185) -0.004  (0.0171)
Basophils, ORAL - DAY 7-10 Number Analyzed 43 participants 29 participants 21 participants
0.001  (0.0277) 0.007  (0.0258) 0.004  (0.0169)
Basophils, POST THERAPY DAY 12-18 Number Analyzed 50 participants 31 participants 19 participants
0.005  (0.0304) 0.001  (0.0217) 0.001  (0.0190)
Basophils, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 1 participants 3 participants
0.016  (0.0114) -0.020 [1]   (NA) -0.007  (0.0404)
Basophils, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
0.040 [1]   (NA)
Eosinophils, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 30 participants 23 participants
0.021  (0.1597) 0.055  (0.1414) 0.052  (0.0744)
Eosinophils, ON IV TREATMENT/DAY 3 Number Analyzed 29 participants 21 participants 9 participants
0.010  (0.1405) 0.024  (0.1474) 0.016  (0.0995)
Eosinophils, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
0.250 [1]   (NA)
Eosinophils, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 6 participants 0 participants
0.026  (0.0826) 0.025  (0.1245)
Eosinophils, ON IV TREATMENT/DAY 7 Number Analyzed 4 participants 1 participants 0 participants
0.055  (0.1723) 0.040 [1]   (NA)
Eosinophils, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
0.010 [1]   (NA)
Eosinophils, ORAL - FIRST DAY Number Analyzed 48 participants 31 participants 22 participants
0.013  (0.1443) 0.051  (0.2001) 0.027  (0.0927)
Eosinophils, ORAL - DAY 7-10 Number Analyzed 43 participants 29 participants 21 participants
0.014  (0.1492) 0.001  (0.1391) 0.052  (0.1066)
Eosinophils, POST THERAPY DAY 12-18 Number Analyzed 50 participants 31 participants 19 participants
-0.017  (0.1168) 0.011  (0.1320) 0.050  (0.1298)
Eosinophils, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 1 participants 3 participants
-0.004  (0.0716) 0.000 [1]   (NA) 0.060  (0.0436)
Eosinophils, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
0.360 [1]   (NA)
Leukocytes, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 30 participants 23 participants
-1.39  (2.722) -1.35  (2.251) -1.47  (2.086)
Leukocytes, ON IV TREATMENT/DAY 3 Number Analyzed 29 participants 21 participants 9 participants
-2.04  (3.091) -1.80  (2.692) -2.94  (4.222)
Leukocytes, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-7.10 [1]   (NA)
Leukocytes, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 6 participants 0 participants
-2.49  (4.376) -2.57  (1.402)
Leukocytes, ON IV TREATMENT/DAY 7 Number Analyzed 4 participants 1 participants 0 participants
-4.55  (5.108) -2.90 [1]   (NA)
Leukocytes, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
-11.20 [1]   (NA)
Leukocytes, ORAL - FIRST DAY Number Analyzed 48 participants 31 participants 22 participants
-1.31  (2.959) -2.32  (2.527) -1.69  (2.641)
Leukocytes, ORAL - DAY 7-10 Number Analyzed 43 participants 29 participants 21 participants
-1.08  (2.482) -1.91  (2.299) -1.67  (2.637)
Leukocytes, POST THERAPY DAY 12-18 Number Analyzed 50 participants 31 participants 19 participants
-2.15  (3.053) -2.20  (2.464) -2.25  (3.152)
Leukocytes, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 1 participants 3 participants
-2.06  (2.428) -5.70 [1]   (NA) -3.23  (5.877)
Leukocytes, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-12.60 [1]   (NA)
Lymphocytes, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 30 participants 23 participants
0.019  (0.6137) 0.009  (0.5047) 0.358  (0.7229)
Lymphocytes, ON IV TREATMENT/DAY 3 Number Analyzed 29 participants 21 participants 9 participants
0.263  (0.5574) 0.094  (0.3504) 0.129  (0.5742)
Lymphocytes, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
0.790 [1]   (NA)
Lymphocytes, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 6 participants 0 participants
0.288  (0.6918) 0.075  (0.5417)
Lymphocytes, ON IV TREATMENT/DAY 7 Number Analyzed 4 participants 1 participants 0 participants
0.705  (0.5291) 0.200 [1]   (NA)
Lymphocytes, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
1.230 [1]   (NA)
Lymphocytes, ORAL - FIRST DAY Number Analyzed 48 participants 31 participants 22 participants
0.002  (0.6844) -0.050  (0.7343) 0.247  (0.8342)
Lymphocytes, ORAL - DAY 7-10 Number Analyzed 43 participants 29 participants 21 participants
0.222  (0.6592) 0.204  (0.7131) 0.284  (0.6655)
Lymphocytes, POST-THERAPY DAY 12-18 Number Analyzed 50 participants 31 participants 19 participants
0.179  (0.7122) 0.028  (0.6588) 0.184  (0.5295)
Lymphocytes, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 1 participants 3 participants
0.326  (0.3564) -0.020 [1]   (NA) 0.097  (0.2743)
Lymphocytes, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
0.850 [1]   (NA)
Monocytes, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 30 participants 23 participants
-0.054  (0.1938) -0.030  (0.2160) -0.011  (0.2524)
Monocytes, ON IV TREATMENT/DAY 3 Number Analyzed 29 participants 21 participants 9 participants
-0.002  (0.2326) -0.133  (0.2330) -0.219  (0.5008)
Monocytes, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-0.280 [1]   (NA)
Monocytes, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 6 participants 0 participants
-0.114  (0.2056) -0.243  (0.2448)
Monocytes, ON IV TREATMENT/DAY 7 Number Analyzed 4 participants 1 participants 0 participants
0.022  (0.3231) -0.170 [1]   (NA)
Monocytes, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
-0.240 [1]   (NA)
Monocytes, ORAL - FIRST DAY Number Analyzed 48 participants 31 participants 22 participants
-0.076  (0.2069) -0.099  (0.2379) -0.154  (0.2919)
Monocytes, ORAL - DAY 7-10 Number Analyzed 43 participants 29 participants 21 participants
-0.014  (0.2030) -0.067  (0.1690) -0.070  (0.3348)
Monocytes, POST THERAPY DAY 12-18 Number Analyzed 50 participants 31 participants 19 participants
-0.077  (0.1442) -0.130  (0.2240) -0.133  (0.3065)
Monocytes, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 1 participants 3 participants
0.018  (0.2969) 0.050 [1]   (NA) -0.347  (0.7050)
Monocytes, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
0.280 [1]   (NA)
Neutrophils, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 30 participants 23 participants
-1.373  (2.7464) -1.395  (2.4280) -1.873  (2.0729)
Neutrophils, ON IV TREATMENT/DAY 3 Number Analyzed 29 participants 21 participants 9 participants
-2.324  (3.2252) -1.789  (2.6403) -2.854  (3.6332)
Neutrophils, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-7.880 [1]   (NA)
Neutrophils, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 6 participants 0 participants
-2.712  (4.5024) -2.445  (0.9370)
Neutrophils, ON IV TREATMENT/DAY 7 Number Analyzed 4 participants 1 participants 0 participants
-5.403  (5.1790) -2.910 [1]   (NA)
Neutrophils, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
-12.250 [1]   (NA)
Neutrophils, ORAL - FIRST DAY Number Analyzed 48 participants 31 participants 22 participants
-1.244  (3.0855) -2.229  (2.6921) -1.802  (2.5066)
Neutrophils, ORAL - DAY 7-10 Number Analyzed 43 participants 29 participants 21 participants
-1.363  (2.4532) -2.068  (2.3963) -1.930  (2.7752)
Neutrophils, POST THERAPY DAY 12-18 Number Analyzed 50 participants 31 participants 19 participants
-2.243  (3.2754) -2.111  (2.6465) -2.346  (3.0470)
Neutrophils, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 1 participants 3 participants
-2.436  (2.5072) -5.770 [1]   (NA) -3.007  (5.4347)
Neutrophils, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
-14.050 [1]   (NA)
Platelets, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 28 participants 21 participants
5.6  (37.64) 6.3  (41.11) -6.7  (57.38)
Platelets, ON IV TREATMENT/DAY 3 Number Analyzed 30 participants 20 participants 8 participants
5.8  (44.94) 3.1  (41.89) -0.6  (19.64)
Platelets, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
-30.0 [1]   (NA)
Platelets, ON IV TREATMENT/DAY 5 Number Analyzed 12 participants 6 participants 0 participants
43.7  (78.78) 21.3  (33.02)
Platelets, ON IV TREATMENT/DAY 7 Number Analyzed 4 participants 1 participants 0 participants
77.8  (107.48) -9.0 [1]   (NA)
Platelets, ON IV TREATMENT/DAY 10 Number Analyzed 1 participants 0 participants 0 participants
159.0 [1]   (NA)
Platelets, ORAL - FIRST DAY Number Analyzed 48 participants 28 participants 21 participants
44.0  (74.12) 0.1  (73.36) 11.6  (52.46)
Platelets, ORAL - DAY 7-10 Number Analyzed 43 participants 28 participants 20 participants
22.7  (55.11) 33.9  (95.63) 22.0  (63.18)
Platelets, POST THERAPY DAY 12-18 Number Analyzed 50 participants 29 participants 18 participants
17.5  (76.72) 2.9  (88.15) 0.6  (56.26)
Platelets, FOLLOW UP DAY 21-28 Number Analyzed 5 participants 1 participants 3 participants
21.0  (26.44) -92.0 [1]   (NA) -23.3  (62.93)
Platelets, POST DOSE DAY 3-10 Number Analyzed 1 participants 0 participants 0 participants
148.0 [1]   (NA)
[1]
Only one participant was analyzed.
43.Secondary Outcome
Title Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hide Description Blood samples for assessment of hematology parameters of EMCHC and hemoglobin was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Time Frame Baseline (Day 1) up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Arm/Group Title Gepotidacin 750 mg q12h Gepotidacin 1000 mg q12h Gepotidacin 1000 mg q8h
Hide Arm/Group Description:
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator’s discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
Overall Number of Participants Analyzed 58 39 25
Mean (Standard Deviation)
Unit of Measure: Gram per liter
EMCHC, ON IV TREATMENT/DAY 2 Number Analyzed 54 participants 30 participants 23 participants
1.2  (6.08) 2.0  (6.90) 0.1  (6.94)
EMCHC, ON IV TREATMENT/DAY 3 Number Analyzed 30 participants 21 participants 9 participants
-0.4  (6.64) 2.9  (7.67) 2.9  (7.90)
EMCHC, ON IV TREATMENT/DAY 4 Number Analyzed 0 participants 1 participants 0 participants
0.0 [1]   (NA)
EMCHC, ON IV TREATMENT/DAY 5 Number Analyzed 13 participants 6 participants 0 participants