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)

NCT03643952

Phase 2 Completed 18 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
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