Trials / Completed
CompletedNCT00770341
A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
A Phase III Randomized, Open-labeled Clinical Trial of MK-3009 (Daptomycin) in Patients With Skin and Soft Tissue Infections, Septicemia and Right-sided Infective Endocarditis Caused by MRSA
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daptomycin 4 mg/kg | MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI) |
| DRUG | Comparator: vancomycin | vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days |
| DRUG | Daptomycin 6 mg/kg | MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2008-10-10
- Last updated
- 2017-03-24
- Results posted
- 2011-06-15
Source: ClinicalTrials.gov record NCT00770341. Inclusion in this directory is not an endorsement.