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

Phase 3

Completed

• Conditions: Staphylococcal Infection
• Interventions: Drug: Daptomycin 6 mg/kg; Drug: Daptomycin 4 mg/kg

• Registration Number: NCT00770341
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Disposition First Submitted: 2011-02-16
• Disposition First Submitted QC: 2011-02-16
• Disposition First Posted: 2011-03-08
• Results First Submitted: 2011-05-17
• Results First Submitted QC: 2011-05-17
• Results First Posted: 2011-06-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

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Exclusion Criteria

• Participants With Skin and Soft Tissue infections That Can Be Treated By Surgery Alone
• Participants With Pneumonia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-3009 (daptomycin) 6 mg/kg	Daptomycin 6 mg/kg	-
MK-3009 (daptomycin) 4 mg/kg	Daptomycin 4 mg/kg	-

Primary Outcome Measures

Name	Time	Method
Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)	7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)	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	7-14 days for SSTI, 14-42 days for septicemia and RIE	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.

Secondary Outcome Measures

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