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
About this trial
This is an interventional treatment trial for Staphylococcal Infection
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
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
NCT ID
NCT00770341
First Posted
October 9, 2008
Last Updated
February 21, 2017
Sponsor
Merck Sharp & Dohme LLC
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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