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GSK2251052 in Complicated Urinary Tract Infection

This study has been terminated.
(Microbiological findings of resistance on therapy in patients with complicated urinary tract infection)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381549
First Posted: June 27, 2011
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: August 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Infections, Urinary Tract
Interventions: Drug: GSK2251052
Drug: imipenem-cilastatin
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at eight centers in three countries (United States, Spain and Greece) from 28-June-2011 to 06-March-2012. A total of 20 participants were randomized in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
It was planned to enroll approximately 210 male and female participants with lower complicated urinary tract infection (cUTI) or pyelonephritis (complicated and uncomplicated); however, due to some unexpected microbiological findings, this study was terminated early with only 20 participants enrolled.

Reporting Groups
  Description
GSK2251052 750 mg Eligible participants received GSK2251052, 750 milligram (mg), in 200 or 250 millilitre (mL) saline solution as intravenous (IV) infusion administered over 60 minutes, twice a day (BID) and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
GSK2251052 1500 mg Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
Imipenem-Cilastatin Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.

Participant Flow:   Overall Study
    GSK2251052 750 mg   GSK2251052 1500 mg   Imipenem-Cilastatin
STARTED   6   8   6 
COMPLETED   6   8   5 
NOT COMPLETED   0   0   1 
Ineligible: No organisms isolated                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GSK2251052 750 mg Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
GSK2251052 1500 mg Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study.
Imipenem-Cilastatin Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study.
Total Total of all reporting groups

Baseline Measures
   GSK2251052 750 mg   GSK2251052 1500 mg   Imipenem-Cilastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   8   6   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.7  (13.60)   50.4  (24.45)   48.0  (17.48)   51.3  (18.95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3  50.0%      4  50.0%      3  50.0%      10  50.0% 
Male      3  50.0%      4  50.0%      3  50.0%      10  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      1  12.5%      1  16.7%      2  10.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  12.5%      0   0.0%      1   5.0% 
White      6 100.0%      6  75.0%      5  83.3%      17  85.0% 
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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

2.  Primary:   Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

3.  Primary:   Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

4.  Primary:   Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

5.  Primary:   Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

6.  Primary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to 28 days post-therapy ]

7.  Primary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings   [ Time Frame: Up to Late Follow-up Visit (21 to 28 days post-IV therapy) ]

8.  Primary:   Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Up to Late Follow up Visit (21 to 28 days post-IV therapy) ]

9.  Primary:   Summary of Vital Signs- Mean Heart Rate   [ Time Frame: Up to Late Follow-up Visit (21 to 28 days post-IV therapy) ]

10.  Primary:   Summary of Vital Signs- Mean Respiration Rate   [ Time Frame: Up to Late Follow-up Visit (21 to 28 days post-IV therapy) ]

11.  Primary:   Summary of Vital Signs- Mean Temperature   [ Time Frame: Up to Late Follow up Visit (21 to 28 days post-IV therapy) ]

12.  Primary:   Therapeutic Response at the Test of Cure Visit   [ Time Frame: Test of Cure Visit (5 to 9 days post-IV therapy) ]

13.  Primary:   Change From Baseline in Hematology Parameters- Hematocrit   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

14.  Primary:   Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

15.  Primary:   Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

16.  Primary:   Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

17.  Primary:   Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

18.  Primary:   Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC)   [ Time Frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) ]

19.  Secondary:   Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit   [ Time Frame: End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy) ]

20.  Secondary:   Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit   [ Time Frame: End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy) ]

21.  Secondary:   Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit   [ Time Frame: End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy) ]

22.  Secondary:   Maximum Plasma Concentration (Cmax) of GSK2251052   [ Time Frame: Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose ]

23.  Secondary:   Area Under the Concentration Time Curve (AUC) of GSK2251052   [ Time Frame: Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose ]

24.  Secondary:   Time to Cmax (Tmax) of GSK2251052   [ Time Frame: Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose ]

25.  Secondary:   Cmax of GSK2251052 Using Non-intensive PK Sampling   [ Time Frame: Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose ]

26.  Secondary:   AUC of GSK2251052 Using Non-intensive PK Sampling   [ Time Frame: Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose ]

27.  Secondary:   Tmax of GSK2251052 Using Non-intensive PK Sampling   [ Time Frame: Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose ]

28.  Secondary:   Cmax of GSK2251052 Using Intensive PK Sampling   [ Time Frame: Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose ]

29.  Secondary:   AUC of GSK2251052 Using Intensive PK Sampling   [ Time Frame: Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose ]

30.  Secondary:   Tmax of GSK2251052 Using Intensive PK Sampling   [ Time Frame: Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381549     History of Changes
Other Study ID Numbers: 114688
First Submitted: June 9, 2011
First Posted: June 27, 2011
Results First Submitted: August 9, 2017
Results First Posted: September 8, 2017
Last Update Posted: September 8, 2017