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Trial record 4 of 19 for:    Infections | Oxacillin

Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections

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.
 
ClinicalTrials.gov Identifier: NCT00711802
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : June 10, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Skin Diseases, Infectious
Interventions Drug: Daptomycin
Drug: Standard of Care (SOC)
Enrollment 396
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Age Group 1: Daptomycin Age Group 1: Standard of Care (SOC) Age Group 2: Daptomycin Age Group 2: SOC Age Group 3: Daptomycin Age Group 3: SOC Age Group 4: Daptomycin Age Group 4: SOC
Hide Arm/Group Description

Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days

Age Group 1: Participants ages 12 to 17 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 1: Participants ages 12 to 17 years

Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days

Age Group 2: Participants ages 7 to 11 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 2: Participants ages 7 to 11 years

Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days

Age Group 3: Participants ages 2 to 6 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 3: Participants ages 2 to 6 years

Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days

Age Group 4: Participants ages 1 to <2 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 4: Participants ages 1 to <2 years

Period Title: Overall Study
Started 75 38 75 38 83 42 30 15
Received at Least 1 Dose of Study Drug 73 37 73 38 81 42 30 15
Completed 73 32 69 35 69 34 25 13
Not Completed 2 6 6 3 14 8 5 2
Reason Not Completed
Not treated (no further detail)             2             1             2             0             2             0             0             0
Adverse Event             0             0             0             0             1             1             0             0
Microbiological failure             0             1             0             0             0             1             0             0
Protocol Violation             0             0             0             1             0             0             0             0
Physician Decision             0             2             0             0             0             0             0             0
Withdrawal by Subject             0             1             0             1             0             0             0             0
Lost to Follow-up             0             0             3             1             10             6             4             2
Reason not reported             0             1             1             0             1             0             1             0
Arm/Group Title Age Group 1: Daptomycin Age Group 1: Standard of Care (SOC) Age Group 2: Daptomycin Age Group 2: SOC Age Group 3: Daptomycin Age Group 3: SOC Age Group 4: Daptomycin Age Group 4: SOC Total
Hide Arm/Group Description

Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days

Age Group 1: Participants ages 12 to 17 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 1: Participants ages 12 to 17 years

Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days

Age Group 2: Participants ages 7 to 11 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 2: Participants ages 7 to 11 years

Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days

Age Group 3: Participants ages 2 to 6 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 3: Participants ages 2 to 6 years

Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days

Age Group 4: Participants ages 1 to <2 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 4: Participants ages 1 to <2 years

Total of all reporting groups
Overall Number of Baseline Participants 73 37 73 38 81 42 30 15 389
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 37 participants 73 participants 38 participants 81 participants 42 participants 30 participants 15 participants 389 participants
15.02  (1.584) 14.84  (1.735) 9.05  (1.443) 8.98  (1.305) 3.92  (1.556) 3.86  (1.555) 1.46  (0.299) 1.43  (0.299) 8.21  (5.134)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 37 participants 73 participants 38 participants 81 participants 42 participants 30 participants 15 participants 389 participants
Female
29
  39.7%
15
  40.5%
28
  38.4%
15
  39.5%
48
  59.3%
20
  47.6%
21
  70.0%
12
  80.0%
188
  48.3%
Male
44
  60.3%
22
  59.5%
45
  61.6%
23
  60.5%
33
  40.7%
22
  52.4%
9
  30.0%
3
  20.0%
201
  51.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 37 participants 73 participants 38 participants 81 participants 42 participants 30 participants 15 participants 389 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
33
  45.2%
16
  43.2%
49
  67.1%
25
  65.8%
1
   1.2%
0
   0.0%
0
   0.0%
1
   6.7%
125
  32.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  16.4%
6
  16.2%
8
  11.0%
5
  13.2%
33
  40.7%
10
  23.8%
12
  40.0%
4
  26.7%
90
  23.1%
White
28
  38.4%
14
  37.8%
15
  20.5%
7
  18.4%
43
  53.1%
31
  73.8%
18
  60.0%
9
  60.0%
165
  42.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
2
   0.5%
Unknown or Not Reported
0
   0.0%
1
   2.7%
1
   1.4%
0
   0.0%
4
   4.9%
0
   0.0%
0
   0.0%
1
   6.7%
7
   1.8%
1.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame Baseline through 14 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.
Arm/Group Title Age Group 1: Daptomycin Age Group 1: Standard of Care (SOC) Age Group 2: Daptomycin Age Group 2: SOC Age Group 3: Daptomycin Age Group 3: SOC Age Group 4: Daptomycin Age Group 4: SOC
Hide Arm/Group Description:

Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days

Age Group 1: Participants ages 12 to 17 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 1: Participants ages 12 to 17 years

Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days

Age Group 2: Participants ages 7 to 11 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 2: Participants ages 7 to 11 years

Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days

Age Group 3: Participants ages 2 to 6 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 3: Participants ages 2 to 6 years

Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days

Age Group 4: Participants ages 1 to <2 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 4: Participants ages 1 to <2 years

Overall Number of Participants Analyzed 72 38 73 38 81 42 30 15
Measure Type: Number
Unit of Measure: percentage of participants
At least 1 TEAE 36.1 36.8 23.3 18.4 50.6 38.1 46.7 73.3
At least 1 drug-related TEAE 13.9 10.5 5.5 10.5 22.2 21.4 10.0 33.3
Discontinued treatment due to a TEAE 2.8 0 1.4 0 3.7 14.3 3.3 6.7
2.Secondary Outcome
Title Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit
Hide Description The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as "Success" or "Failure" by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered "Success" by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of “Failure” was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was “Failure.” If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was "Unable to evaluate."
Time Frame Baseline through 14 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.
Arm/Group Title Age Group 1: Daptomycin Age Group 1: Standard of Care (SOC) Age Group 2: Daptomycin Age Group 2: SOC Age Group 3: Daptomycin Age Group 3: SOC Age Group 4: Daptomycin Age Group 4: SOC
Hide Arm/Group Description:

Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days

Age Group 1: Participants ages 12 to 17 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 1: Participants ages 12 to 17 years

Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days

Age Group 2: Participants ages 7 to 11 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 2: Participants ages 7 to 11 years

Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days

Age Group 3: Participants ages 2 to 6 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 3: Participants ages 2 to 6 years

Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days

Age Group 4: Participants ages 1 to <2 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 4: Participants ages 1 to <2 years

Overall Number of Participants Analyzed 73 37 73 38 81 42 30 15
Measure Type: Number
Unit of Measure: percentage of participants
Clinical success 95.9 91.9 90.4 92.1 82.7 76.2 80.0 86.7
Clinical failure 0 2.7 2.7 0 1.2 0 0 0
Unable to evaluate 4.1 5.4 6.9 7.9 16.1 23.8 20.0 13.3
3.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])
Hide Description

Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points:

Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion.

Time Frame Predose and 5 timepoints according to age group (up to 12 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.
Arm/Group Title Age Group 1: Daptomycin Age Group 2: Daptomycin Age Group 3: Daptomycin Age Group 4: Daptomycin
Hide Arm/Group Description:

Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days

Age Group 1: Participants ages 12 to 17 years

Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days

Age Group 2: Participants ages 7 to 11 years

Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days

Age Group 3: Participants ages 2 to 6 years

Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days

Age Group 4: Participants ages 1 to <2 years

Overall Number of Participants Analyzed 6 2 7 30
Mean (Standard Deviation)
Unit of Measure: microgram*hour per milliliter (μg*hr/mL)
318  (62.2) NA [1]   (NA) 318  (68.6) 466 [2]   (NA)
[1]
Due to limited pharmacokinetic (PK) samples, these measures could not be calculated.
[2]
Due to limited PK samples, PK parameters were computed using the mean concentration-time profile during a sampling interval. As a result, no variability could be calculated.
Time Frame Baseline through 14 days after last dose of study drug
Adverse Event Reporting Description Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
 
Arm/Group Title Age Group 1: Daptomycin Age Group 1: Standard of Care (SOC) Age Group 2: Daptomycin Age Group 2: SOC Age Group 3: Daptomycin Age Group 3: SOC Age Group 4: Daptomycin Age Group 4: SOC
Hide Arm/Group Description

Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days

Age Group 1: Participants ages 12 to 17 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 1: Participants ages 12 to 17 years

Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days

Age Group 2: Participants ages 7 to 11 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 2: Participants ages 7 to 11 years

Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days

Age Group 3: Participants ages 2 to 6 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 3: Participants ages 2 to 6 years

Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days

Age Group 4: Participants ages 1 to <2 years

SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.

Age Group 4: Participants ages 1 to <2 years

All-Cause Mortality
Age Group 1: Daptomycin Age Group 1: Standard of Care (SOC) Age Group 2: Daptomycin Age Group 2: SOC Age Group 3: Daptomycin Age Group 3: SOC Age Group 4: Daptomycin Age Group 4: SOC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Age Group 1: Daptomycin Age Group 1: Standard of Care (SOC) Age Group 2: Daptomycin Age Group 2: SOC Age Group 3: Daptomycin Age Group 3: SOC Age Group 4: Daptomycin Age Group 4: SOC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/72 (4.17%)      1/38 (2.63%)      1/73 (1.37%)      1/38 (2.63%)      2/81 (2.47%)      1/42 (2.38%)      0/30 (0.00%)      0/15 (0.00%)    
General disorders                 
Chest pain  1/72 (1.39%)  1 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Pyrexia  0/72 (0.00%)  0 0/38 (0.00%)  0 1/73 (1.37%)  1 0/38 (0.00%)  0 1/81 (1.23%)  1 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations                 
Abscess  0/72 (0.00%)  0 0/38 (0.00%)  0 1/73 (1.37%)  1 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Bacteraemia  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 1/42 (2.38%)  1 0/30 (0.00%)  0 0/15 (0.00%)  0
Osteomyelitis  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 1/38 (2.63%)  2 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Subcutaneous abscess  1/72 (1.39%)  1 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Toxic shock syndrome  0/72 (0.00%)  0 1/38 (2.63%)  1 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Investigations                 
Blood creatine phosphokinase increased  1/72 (1.39%)  1 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Myopathy  1/72 (1.39%)  1 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Status asthmaticus  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 1/81 (1.23%)  1 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Surgical and medical procedures                 
Wound drainage  0/72 (0.00%)  0 0/38 (0.00%)  0 1/73 (1.37%)  1 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
Age Group 1: Daptomycin Age Group 1: Standard of Care (SOC) Age Group 2: Daptomycin Age Group 2: SOC Age Group 3: Daptomycin Age Group 3: SOC Age Group 4: Daptomycin Age Group 4: SOC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/72 (20.83%)      9/38 (23.68%)      7/73 (9.59%)      2/38 (5.26%)      27/81 (33.33%)      10/42 (23.81%)      11/30 (36.67%)      11/15 (73.33%)    
Gastrointestinal disorders                 
Cheilitis  0/72 (0.00%)  0 1/38 (2.63%)  1 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Diarrhoea  3/72 (4.17%)  3 1/38 (2.63%)  1 3/73 (4.11%)  3 1/38 (2.63%)  1 12/81 (14.81%)  13 4/42 (9.52%)  4 0/30 (0.00%)  0 1/15 (6.67%)  1
Nausea  2/72 (2.78%)  3 0/38 (0.00%)  0 1/73 (1.37%)  1 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Vomiting  0/72 (0.00%)  0 0/38 (0.00%)  0 1/73 (1.37%)  1 0/38 (0.00%)  0 4/81 (4.94%)  4 1/42 (2.38%)  1 2/30 (6.67%)  3 0/15 (0.00%)  0
General disorders                 
Infusion site extravasation  1/72 (1.39%)  1 1/38 (2.63%)  1 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Infusion site pain  1/72 (1.39%)  1 2/38 (5.26%)  2 1/73 (1.37%)  1 0/38 (0.00%)  0 1/81 (1.23%)  1 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Pyrexia  2/72 (2.78%)  2 0/38 (0.00%)  0 4/73 (5.48%)  4 0/38 (0.00%)  0 1/81 (1.23%)  1 1/42 (2.38%)  1 2/30 (6.67%)  2 3/15 (20.00%)  3
Infections and infestations                 
Abscess neck  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Candida nappy rash  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 1/30 (3.33%)  1 1/15 (6.67%)  1
Cellulitis  1/72 (1.39%)  1 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 1/81 (1.23%)  1 0/42 (0.00%)  0 2/30 (6.67%)  2 0/15 (0.00%)  0
Fungal infection  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 1/81 (1.23%)  1 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Genital candidiasis  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Hand-foot-and-mouth disease  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Rhinitis  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Upper respiratory tract infection  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 1/38 (2.63%)  1 0/81 (0.00%)  0 1/42 (2.38%)  1 0/30 (0.00%)  0 1/15 (6.67%)  1
Investigations                 
Blood creatine phosphokinase increased  4/72 (5.56%)  4 2/38 (5.26%)  2 0/73 (0.00%)  0 1/38 (2.63%)  1 8/81 (9.88%)  8 2/42 (4.76%)  2 1/30 (3.33%)  1 2/15 (13.33%)  2
Blood phosphorus increased  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 1/81 (1.23%)  1 0/42 (0.00%)  0 1/30 (3.33%)  1 1/15 (6.67%)  1
Lymphocyte percentage increase  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Neutrophil count decreased  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Platelet count increased  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Red blood cells urine  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Metabolism and nutrition disorders                 
Hyperphosphataemia  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 1/81 (1.23%)  1 0/42 (0.00%)  0 2/30 (6.67%)  2 0/15 (0.00%)  0
Nervous system disorders                 
Headache  5/72 (6.94%)  5 3/38 (7.89%)  4 2/73 (2.74%)  2 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Pharyngeal lesion  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 0/42 (0.00%)  0 0/30 (0.00%)  0 1/15 (6.67%)  1
Rhinorrhoea  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 1/38 (2.63%)  1 2/81 (2.47%)  2 0/42 (0.00%)  0 2/30 (6.67%)  2 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Dermatitis diaper  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 1/42 (2.38%)  1 2/30 (6.67%)  2 2/15 (13.33%)  2
Rash  0/72 (0.00%)  0 1/38 (2.63%)  1 0/73 (0.00%)  0 0/38 (0.00%)  0 1/81 (1.23%)  1 2/42 (4.76%)  2 0/30 (0.00%)  0 1/15 (6.67%)  1
Rash papular  1/72 (1.39%)  1 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 1/42 (2.38%)  1 2/30 (6.67%)  2 0/15 (0.00%)  0
Urticaria  0/72 (0.00%)  0 0/38 (0.00%)  0 0/73 (0.00%)  0 0/38 (0.00%)  0 0/81 (0.00%)  0 1/42 (2.38%)  1 0/30 (0.00%)  0 1/15 (6.67%)  1
1
Term from vocabulary, MedDRA (11.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals
Phone: (781) 860-8660
Layout table for additonal information
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00711802     History of Changes
Other Study ID Numbers: 3009-017
DAP-PEDS-07-03 ( Other Identifier: Cubist Study Number )
First Submitted: July 7, 2008
First Posted: July 9, 2008
Results First Submitted: May 27, 2015
Results First Posted: June 10, 2015
Last Update Posted: September 5, 2018