A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Staphylococcal Infection

Intervention / Treatment
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* Drug: Daptomycin 4 mg/kg
* Drug: Comparator: vancomycin
* Drug: Daptomycin 6 mg/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-3009 (daptomycin) 4 mg/kg<br> | Drug: Daptomycin 4 mg/kg<br>* MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)<br>* Other names: MK3009;|
| Active Comparator: Vancomycin<br> | Drug: Comparator: vancomycin<br>* vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days<br>|
| Experimental: MK-3009 (daptomycin) 6 mg/kg<br> | Drug: Daptomycin 6 mg/kg<br>* MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) | 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. | 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE) | 
| Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC | 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. | 7-14 days for SSTI, 14-42 days for septicemia and RIE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT). | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | 7-14 days for SSTI, 14-42 days for septicemia and RIE | 
| EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT). | 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. | 7-14 days for SSTI, 14-42 days for septicemia and RIE | 
| Study Investigators' Assessment of Clinical Response at EOT | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | 7-14 days for SSTI, 14-42 days for septicemia and RIE | 
| Study Investigators' Assessment of Clinical Response at TOC | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | 7-14 days for SSTI, 14-42 days for septicemia and RIE |