Trials / Completed
CompletedNCT03643952
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)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daptomycin for Injection | 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. |
Timeline
- Start date
- 2018-12-06
- Primary completion
- 2020-04-07
- Completion
- 2020-04-07
- First posted
- 2018-08-23
- Last updated
- 2022-05-13
- Results posted
- 2021-03-30
Locations
16 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03643952. Inclusion in this directory is not an endorsement.