Phase 3
Completed N=122
A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
Staphylococcal Infection
Source: ClinicalTrials.gov NCT00770341 ↗
Enrolled (actual)
122
Serious AEs
11.5%
Results posted
Jun 2011
Primary outcomePrimary: Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) — 45; 16; 2 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) |
45; 16; 2 | — |
| PRIMARY Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC |
31; 9; 2 | — |
| SECONDARY EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT). |
46; 16; 2 | — |
| SECONDARY EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT). |
24; 9; 4 | — |
| SECONDARY Study Investigators' Assessment of Clinical Response at EOT |
47; 18; 3 | — |
| SECONDARY Study Investigators' Assessment of Clinical Response at TOC |
48; 17; 2 | — |
Eligibility Criteria
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 By Surgery Alone
- Participants With Pneumonia
Data sourced from ClinicalTrials.gov (NCT00770341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.