Overview

Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections

Status:
Terminated
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
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 relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cubist Pharmaceuticals LLC
Treatments:
Daptomycin
Criteria
Inclusion Criteria: - 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 Criteria: - Known
bacteremia, osteomyelitis or endocarditis