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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Staphylococcal Infection

Treatments: Drug: Daptomycin 4 mg/kg; Drug: Daptomycin 6 mg/kg; Drug: Comparator: vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770341

3009-002

2008_564

Details and patient eligibility

About

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).

Enrollment: 122 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 3 patient groups

MK-3009 (daptomycin) 4 mg/kg

Experimental group

Treatment:

Drug: Daptomycin 4 mg/kg

Vancomycin

Active Comparator group

Treatment:

Drug: Comparator: vancomycin

MK-3009 (daptomycin) 6 mg/kg

Experimental group

Treatment:

Drug: Daptomycin 6 mg/kg