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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)
vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days
MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis
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.
Time frame: 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.
Time frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE