At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Daptomycin for Injectiondrug
Likely dose
Daptomycin for Injection 12 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Open-Label, Single-arm Clinical Trial to Study the Safety, Efficacy and Pharmacokinetics of MK-3009 (Daptomycin) in Japanese Pediatric Participants Aged 1 to 17 Years With Complicated Skin and Soft Tissue Infections or Bacteremia Caused by Gram-positive Cocci
In Brief
A Phase 2 clinical trial evaluating Daptomycin for Injection for Bacteremia and 2 related conditions. Completed, enrolled 18 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartDec 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedAug 23, 2018
Enrollment StartDec 6, 2018
Primary CompletionApr 7, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.9 years ago
Interventions
Daptomycin for Injectiondrug
Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.