Clinical trial NCT00770341: A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Staphylococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)
timeFrame: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)
measure: Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC
timeFrame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
Secondary outcomes:
measure: EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).
timeFrame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
measure: EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).
timeFrame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
measure: Study Investigators' Assessment of Clinical Response at EOT
timeFrame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
measure: Study Investigators' Assessment of Clinical Response at TOC
timeFrame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Aikawa N, Kusachi S, Mikamo H, Takesue Y, Watanabe S, Tanaka Y, Morita A, Tsumori K, Kato Y, Yoshinari T. Efficacy and safety of intravenous daptomycin in Japanese patients with skin and soft tissue infections. J Infect Chemother. 2013 Jun;19(3):447-55. doi: 10.1007/s10156-012-0501-9. Epub 2012 Oct 20.
citation: Takesue Y, Mikamo H, Kusachi S, Watanabe S, Takahashi K, Yoshinari T, Ishii M, Aikawa N. Correlation between pharmacokinetic/pharmacodynamic indices and clinical outcomes in Japanese patients with skin and soft tissue infections treated with daptomycin: analysis of a phase III study. Diagn Microbiol Infect Dis. 2015 Sep;83(1):77-81. doi: 10.1016/j.diagmicrobio.2015.05.013. Epub 2015 May 28.