Conditions: Skin Diseases, Infectious
Keywords: Complicated Skin Structure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 396
Healthy volunteers: no

Brief summary:
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens.

Detailed description:
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and PK of daptomycin in pediatric participants ages 1 to 17 years, inclusive, with cSSSI caused by Gram-positive pathogens. Participants will be enrolled into age groups and given age-dependent doses over a period of up to 14 days. Participants will be stratified by age group to receive either daptomycin or SOC (recommended as vancomycin, clindamycin or semisynthetic penicillin) in a ratio of 2:1, respectively. Participants may continue on oral therapy following completion of IV study drug administration and provided that the participant meets all criteria for conversion to oral therapy, including clear clinical improvement and availability of an oral agent to which the pathogen is susceptible. The choice of oral therapy will be left to the discretion of the Investigator. February 11, 2015 released from post marketing requirement to include subjects aged 3 months - \< 1 year. Ref ID: 3701325

Arms:
arm 1: 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 arm 2: 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.

Interventions: intervention 1: Daptomycin intervention 2: Standard of Care (SOC)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: