A Study of MK3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-Resistant Staphylococcus Aureus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00770341

Purpose

The study investigates the efficacy and safety of MK3009 in patients with skin infections and septicemia caused by MRSA.

Condition	Intervention	Phase
Staphylococcal Infection	Drug: daptomycin Drug: Comparator: vancomycin	Phase III

MedlinePlus related topics: Sepsis Staphylococcal Infections

Drug Information available for: Vancomycin Daptomycin Vancomycin hydrochloride Methicillin Methicillin sodium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized, Open-Labeled Clinical Trial of MK3009 (Daptomycin) in Patients With Skin and Soft Tissue Infections, Septicemia and Right-Sided Infective Endocarditis Caused by MRSA

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage of patients with clinical success at Test of Cure (TOC). Percentage of patients with microbiological success at TOC. [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with clinical success at End of Treatment (EOT). Percentage of patients with microbiological success at EOT. [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	123
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK3009 (daptomycin)	Drug: daptomycin MK3009 (daptomycin), 4 or 6 mg/kg, once daily by IV drip, 42 days
2: Active Comparator vancomycin	Drug: Comparator: vancomycin vancomycin 1g, bid by IV drip, 14 days

Eligibility

Criteria

Inclusion Criteria:

Both Sexes, Aged 20 Years Or Older
Japanese Patients With Skin And Skin Structure Infections Or Septicemia Known Or Suspected To Be Caused By MRSA
Written Informed Consent

Exclusion Criteria:

Contacts and Locations

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

Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_564, MK3009-002
Study First Received:	October 9, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00770341
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Bacterial Infections
Soft Tissue Infections
Bacterial endocarditis
Endocarditis
Daptomycin
Staphylococcal Infections
Sepsis

Gram-Positive Bacterial Infections
Methicillin
Endocarditis, Bacterial
Infective endocarditis
Endocarditis, infective
Vancomycin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009