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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00770341
First received: October 9, 2008
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Staphylococcal Infection
Drug: Daptomycin 4 mg/kg
Drug: Comparator: vancomycin
Drug: Daptomycin 6 mg/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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 [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]

    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). [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]
    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). [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]

    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 [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE ] [ Designated as safety issue: No ]
    Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.


Enrollment: 122
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770341

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00770341     History of Changes
Other Study ID Numbers: 3009-002, 2008_564
Study First Received: October 9, 2008
Results First Received: May 17, 2011
Last Updated: August 19, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 20, 2014