A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
NCT ID: NCT00770341
Last Updated: 2017-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
122 participants
INTERVENTIONAL
2008-09-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MK-3009 (daptomycin) 4 mg/kg
Daptomycin 4 mg/kg
MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)
Vancomycin
Comparator: vancomycin
vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days
MK-3009 (daptomycin) 6 mg/kg
Daptomycin 6 mg/kg
MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis
Interventions
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Daptomycin 4 mg/kg
MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)
Comparator: vancomycin
vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days
Daptomycin 6 mg/kg
MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Pneumonia
20 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
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.
Other Identifiers
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2008_564
Identifier Type: -
Identifier Source: secondary_id
3009-002
Identifier Type: -
Identifier Source: org_study_id
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