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

Staphylococcal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770341
• Other study ID #: 3009-002
• Secondary ID: 2008_564
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2008
• Last updated: February 21, 2017
• Start date: September 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Staphylococcal Infection
• Staphylococcal Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)
Primary	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.	7-14 days for SSTI, 14-42 days for septicemia and RIE
Secondary	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.	7-14 days for SSTI, 14-42 days for septicemia and RIE
Secondary	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.	7-14 days for SSTI, 14-42 days for septicemia and RIE
Secondary	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.	7-14 days for SSTI, 14-42 days for septicemia and RIE
Secondary	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.	7-14 days for SSTI, 14-42 days for septicemia and RIE