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NCT00102947 Clinical Trial

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

Soft Tissue Infections Clinical Trial

Official title:
An Open Label Phase 4 Trial to Further Evaluate the Pharmacokinetic Profile of Intravenous Daptomycin, and a Comparison of the Safety and Efficacy of Daptomycin Versus Comparator in the Treatment of Adult Patients With Renal Impairment and Complicated Skin and Skin Structure Infections Due, at Least in Part, to Gram-positive Bacteria

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00102947
Other study ID # 3009-020
Secondary ID DAP-REN-03-06
Status Terminated
Phase Phase 4
First received February 4, 2005
Last updated July 22, 2016
Start date January 2005
Est. completion date November 2006

Study information
Verified date July 2016
Source Cubist Pharmaceuticals LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 72
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• daptomycin (up to 14 days)

Locations
Country Name City State
United States Joseph M. Still Research Institute Augusta Georgia
United States St. Luke's Hospital Bethlehem Pennsylvania
United States Upstate Clinical Research Associates Buffalo New York
United States Riverside Methodist Hospital Columbus Ohio
United States Wright State University/Veterans Affairs Medical Center Dayton Ohio
United States Infectious Diseases Minneapolis-LTD Minneapolis Minnesota
United States University of Rochester Medical Center Rochester New York
United States Tampa General Hospital Tampa Florida
United States ID Clinical Research Toledo Ohio
United States Harbor UCLA Medical Center Torrance California
United States The Reading Hospital and Medical Center West Reading Pennsylvania
United States AllTrials Clinical Research Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment
Secondary To compare the safety and efficacy of daptomycin to comparator in patients with complicated skin and skin structure infections and renal impairment at 14 to 21 days after last dose
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