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NCT Number: NCT00770341

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

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).

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Key information

Conditions

Staphylococcal Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Staphylococcal Infections

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daptomycin 4 mg/kg

Drug

MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)

Other names: MK3009

Comparator: vancomycin

Drug

vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days

Daptomycin 6 mg/kg

Drug

MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 10, 2008
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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