Phase 3 N=122 Randomized Treatment

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

Staphylococcal Infection

Bottom Line

View on ClinicalTrials.gov: NCT00770341 ↗

Enrolled (actual)

122

Serious AEs

11.5%

Results posted

Jun 2011

Primary outcome: Primary: Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) — 45; 16; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Daptomycin 4 mg/kg (Drug); Comparator: vancomycin (Drug); Daptomycin 6 mg/kg (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)	45; 16; 2	—
PRIMARY Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC	31; 9; 2	—
SECONDARY EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).	46; 16; 2	—
SECONDARY EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).	24; 9; 4	—
SECONDARY Study Investigators' Assessment of Clinical Response at EOT	47; 18; 3	—
SECONDARY Study Investigators' Assessment of Clinical Response at TOC	48; 17; 2	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00770341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.