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Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment

2014-08-27 03:14:33 | BioPortfolio

Summary

This is a multicenter, randomized, evaluator-blinded, comparator-controlled study. 1:1 randomization daptomycin or comparator, stratified by degree of renal impairment [creatinine clearance(CLcr) 30 - 50 mL/min and <30 mL/min] and by type of infection [bacteremia and complicated Skin and Skin Structure Infections (cSSSI)] to create 4 cohorts defined as follows:

1. Bacteremia and CLcr <30 mL/min

2. Bacteremia and CLcr 30 - 50 mL/min

3. cSSSI and CLcr <30 mL/min

4. cSSSI and CLcr 30 - 50 mL/min

Patients will be treated and evaluated for safety, microbiological and clinical efficacy in accordance with their type of infection and degree of renal impairment. Peak and trough samples will be collected to assess exposure to daptomycin for patients on Day 1 and following the 5th dose.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Complicated Skin and Skin Structure Infections

Intervention

Vancomycin, Vancomycin, Daptomycin 7-14 days moderate renal impairment, Daptomycin 7 - 14 days severe renal impairment, hemodialysis, Daptomycin 7 - 14 days severe renal impairment no hemodialysis, Daptomycin 14 - 42 days, moderate renal impairment, Dapto

Location

LA Biomedical Research Institute at Harbor UCLA Med Ctr
Torrance
California
United States
90502

Status

Recruiting

Source

Cubist Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:33-0400

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