drugset / Trial / NCT00711802
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2008-07-23
- Primary completion
- 2013-10-11
- Completion
- 2013-10-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clindamycin | Unknown | — | Intravenous |
| Subject | Daptomycin | Other / unclassified | 5 mg/kg | Intravenous |
| Subject | Daptomycin | Other / unclassified | 7 mg/kg | Intravenous |
| Subject | Daptomycin | Other / unclassified | 9 mg/kg | Intravenous |
| Subject | Daptomycin | Other / unclassified | 10 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | — | Intravenous |
| Comparator | cloxacillin | Other / unclassified | — | Intravenous |
| Comparator | nafcillin | Small molecule | — | Intravenous |
| Comparator | oxacillin | Small molecule | — | Intravenous |