A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Staphylococcal Infection |
Drug: Daptomycin 4 mg/kg Drug: Comparator: vancomycin Drug: Daptomycin 6 mg/kg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE) ] [ Designated as safety issue: No ]
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.
- Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]
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.
- EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT). [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.
- EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT). [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]
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.
- Study Investigators' Assessment of Clinical Response at EOT [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.
- Study Investigators' Assessment of Clinical Response at TOC [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.
| Enrollment: | 122 |
| Study Start Date: | November 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MK-3009 (daptomycin) 4 mg/kg |
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)
Other Name: MK3009
|
| Active Comparator: Vancomycin |
Drug: Comparator: vancomycin
vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days
|
| Experimental: MK-3009 (daptomycin) 6 mg/kg |
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
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00770341 History of Changes |
| Other Study ID Numbers: | MK-3009-002, 2008_564 |
| Study First Received: | October 9, 2008 |
| Results First Received: | May 17, 2011 |
| Last Updated: | May 17, 2011 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Staphylococcal Infections Soft Tissue Infections Heart Diseases Cardiovascular Diseases Gram-Positive Bacterial Infections Bacterial Infections Infection |
Endocarditis Vancomycin Daptomycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013