Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
|Skin Diseases, Infectious||Drug: Daptomycin Drug: Standard of Care (SOC)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged One to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens|
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through 14 days after last dose of study drug ]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.
- Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit [ Time Frame: Baseline through 14 days after last dose of study drug ]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."
- Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t]) [ Time Frame: Predose and 5 timepoints according to age group (up to 12 hours postdose) ]
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.
|Actual Study Start Date:||July 23, 2008|
|Study Completion Date:||October 11, 2013|
|Primary Completion Date:||October 11, 2013 (Final data collection date for primary outcome measure)|
Administered intravenously (IV) every 24 hours for up to 14 days at the following age-dependent dosages.
Participants ages 7 to 17 years: daptomycin was dissolved in a volume of 50 milliliters (mL) 0.9% sodium chloride for injection over 30 minutes (min) with an infusion rate of 1.67 mL/min.
Participants 1 to 6 years-old: daptomycin was dissolved in a volume of 25 mL 0.9% sodium chloride for injection over 60 min with an infusion rate was 0.42 mL/min.
Age Group 1 (for ages 12 to 17 years): 5 milligrams/kilogram (mg/kg)
Age Group 2 (for ages 7 to 11 years): 7 mg/kg
Age Group 3 (for ages 2 to 6 years): 9 mg/kg
Age Group 4 (for ages 1 to <2 years): 10 mg/kg
Other Name: Cubicin
Active Comparator: Standard of Care (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.
Drug: Standard of Care (SOC)
Other Name: nafcillin, oxacillin, cloxacillin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711802
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|Study Director:||Ellie Hershberger||Cubist Pharmaceuticals LLC|