drugset / Trial / NCT00770341
A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2008-09
- Primary completion
- 2010-02
- Completion
- 2010-02
Publications
- Results Aikawa N, Kusachi S, Mikamo H, Takesue Y, Watanabe S, Tanaka Y, Morita A, Tsumori K, Kato Y, Yoshinari T. Efficacy and safety of intravenous daptomycin in Japanese patients with skin and soft tissue infections. J Infect Chemother. 2013 Jun;19(3):447-55. doi: 10.1007/s10156-012-0501-9. Epub 2012 Oct 20.
- Takesue Y, Mikamo H, Kusachi S, Watanabe S, Takahashi K, Yoshinari T, Ishii M, Aikawa N. Correlation between pharmacokinetic/pharmacodynamic indices and clinical outcomes in Japanese patients with skin and soft tissue infections treated with daptomycin: analysis of a phase III study. Diagn Microbiol Infect Dis. 2015 Sep;83(1):77-81. doi: 10.1016/j.diagmicrobio.2015.05.013. Epub 2015 May 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daptomycin | Other / unclassified | 4 mg/kg | Intravenous |
| Subject | Daptomycin | Other / unclassified | 6 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 1 g | Intravenous |