Status:
TERMINATED
Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Soft Tissue Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of daptomycin r...
Eligibility Criteria
Inclusion
- Moderate to end-stage renal impairment - A diagnosis of complicated skin and skin structure infection known or suspected to be due to susceptible Gram-positive bacteria based on positive Gram stain - A diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor
Exclusion
- Known bacteremia, osteomyelitis or endocarditis
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00102947
Start Date
January 1 2005
End Date
November 1 2006
Last Update
July 25 2016
Active Locations (12)
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1
Harbor UCLA Medical Center
Torrance, California, United States, 90509
2
Tampa General Hospital
Tampa, Florida, United States, 33606
3
Joseph M. Still Research Institute
Augusta, Georgia, United States
4
Infectious Diseases Minneapolis-LTD
Minneapolis, Minnesota, United States, 55422