drugset / Trial / NCT03643952
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection (cSSTI) or bacteremia caused by gram-positive cocci.
Timeline
- Start
- 2018-12-06
- Primary completion
- 2020-04-07
- Completion
- 2020-04-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |
| Subject | Daptomycin | Other / unclassified | 12 mg/kg | Intravenous |