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

NCT00770341 | Completed Phase 3 Results

• 2 other identifiers: 3009-0022008_564
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Staphylococcal Infection

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).

  7-14 days for SSTI, 14-42 days for septicemia and RIE

• EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).

  7-14 days for SSTI, 14-42 days for septicemia and RIE

• Study Investigators' Assessment of Clinical Response at EOT

  7-14 days for SSTI, 14-42 days for septicemia and RIE

• Study Investigators' Assessment of Clinical Response at TOC

  7-14 days for SSTI, 14-42 days for septicemia and RIE

Study Arms (3)

MK-3009 (daptomycin) 4 mg/kg

EXPERIMENTAL

Drug: Daptomycin 4 mg/kg

Vancomycin

ACTIVE COMPARATOR

Drug: Comparator: vancomycin

MK-3009 (daptomycin) 6 mg/kg

EXPERIMENTAL

Drug: Daptomycin 6 mg/kg

Interventions

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)

Also known as: MK3009

MK-3009 (daptomycin) 4 mg/kg

Comparator: vancomycin DRUG

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

Vancomycin

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

MK-3009 (daptomycin) 6 mg/kg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants With Skin and Soft Tissue infections That Can Be Treated By Surgery Alone
• Participants With Pneumonia

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• 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.

  PMID: 23085743 RESULT

• 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.

  PMID: 26072149 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@Merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 24, 2017
• Results First Posted: June 15, 2011

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share