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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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ClinicalTrials.gov Identifier: NCT00770341
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : June 15, 2011
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Staphylococcal Infection Drug: Daptomycin 4 mg/kg Drug: Comparator: vancomycin Drug: Daptomycin 6 mg/kg Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010


Arms and Interventions

Arm Intervention/treatment
Experimental: MK-3009 (daptomycin) 4 mg/kg Drug: 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)
Other Name: MK3009
Active Comparator: Vancomycin Drug: Comparator: vancomycin
vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days
Experimental: MK-3009 (daptomycin) 6 mg/kg Drug: 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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE) ]

    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.


  2. Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ]

    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 :
  1. EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT). [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ]
    Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.

  2. EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT). [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ]

    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.


  3. Study Investigators' Assessment of Clinical Response at EOT [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ]
    Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.

  4. Study Investigators' Assessment of Clinical Response at TOC [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ]
    Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770341


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00770341     History of Changes
Other Study ID Numbers: 3009-002
2008_564
First Posted: October 10, 2008    Key Record Dates
Results First Posted: June 15, 2011
Last Update Posted: March 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


Additional relevant MeSH terms:
Infection
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents