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

Phase 4

Terminated

• Conditions: Soft Tissue Infections

• Registration Number: NCT00102947
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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 relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-02-04
• Study First Submitted QC: 2005-02-04
• Study First Posted: 2005-02-07
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-22
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Joseph M. Still Research Institute; 🇺🇸 Augusta, Georgia, United States

Harbor UCLA Medical Center; 🇺🇸 Torrance, California, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Infectious Diseases Minneapolis-LTD; 🇺🇸 Minneapolis, Minnesota, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

AllTrials Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

ID Clinical Research; 🇺🇸 Toledo, Ohio, United States

Wright State University/Veterans Affairs Medical Center; 🇺🇸 Dayton, Ohio, United States

The Reading Hospital and Medical Center; 🇺🇸 West Reading, Pennsylvania, United States

Upstate Clinical Research Associates; 🇺🇸 Buffalo, New York, United States

St. Luke's Hospital; 🇺🇸 Bethlehem, Pennsylvania, United States