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

Primary Purpose

Staphylococcal Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Daptomycin 4 mg/kg
Comparator: vancomycin
Daptomycin 6 mg/kg
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcal Infection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Arm Label

    MK-3009 (daptomycin) 4 mg/kg

    Vancomycin

    MK-3009 (daptomycin) 6 mg/kg

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    October 9, 2008
    Last Updated
    February 21, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00770341
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Staphylococcal Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    122 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-3009 (daptomycin) 4 mg/kg
    Arm Type
    Experimental
    Arm Title
    Vancomycin
    Arm Type
    Active Comparator
    Arm Title
    MK-3009 (daptomycin) 6 mg/kg
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Daptomycin 4 mg/kg
    Other Intervention Name(s)
    MK3009
    Intervention Description
    MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: vancomycin
    Intervention Description
    vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Daptomycin 6 mg/kg
    Intervention Description
    MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis
    Primary Outcome Measure Information:
    Title
    Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)
    Description
    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)
    Title
    Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC
    Description
    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
    Secondary Outcome Measure Information:
    Title
    EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).
    Description
    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
    Title
    EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).
    Description
    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
    Title
    Study Investigators' Assessment of Clinical Response at EOT
    Description
    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
    Title
    Study Investigators' Assessment of Clinical Response at TOC
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23085743
    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.
    Results Reference
    result
    PubMed Identifier
    26072149
    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.
    Results Reference
    derived

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

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