Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00770341 | A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002) | PHASE3 | COMPLETED | 122 | — | — | Sep 1, 2008 | Feb 1, 2010 | Mar 24, 2017 | - | — |
Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT). MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline.
Response = eradicated or presumed eradicated. Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen. Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen.
| Arm | Type | Description |
|---|---|---|
| MK-3009 (daptomycin) 4 mg/kg | EXPERIMENTAL | - |
| Vancomycin | ACTIVE_COMPARATOR | - |
| MK-3009 (daptomycin) 6 mg/kg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Daptomycin 4 mg/kg | DRUG | MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI) |
| Comparator: vancomycin | DRUG | vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days |
| Daptomycin 6 mg/kg | DRUG | MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis |
Inclusion Criteria: * Both Sexes, Aged 20 Years Or Older * Japanese Participants With Skin And Soft Tissue Infections, Septicemia, or RIE Known Or Suspected To Be Caused By MRSA * Written Informed Consent Exclusion Criteria: * Participants With Skin and Soft Tissue infections That Can Be Treated ...