Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
Information source: Cubist Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Soft Tissue Infections
Intervention: daptomycin (up to 14 days) (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Cubist Pharmaceuticals
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: 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: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Harbor UCLA Medical Center, Torrance, California 90509, United States
Tampa General Hospital, Tampa, Florida 33606, United States
Joseph M. Still Research Institute, Augusta, Georgia, United States
Infectious Diseases Minneapolis-LTD, Minneapolis, Minnesota 55422, United States
University of Rochester Medical Center, Rochester, New York 14642, United States
Upstate Clinical Research Associates, Buffalo, New York 14203, United States
AllTrials Clinical Research, Winston-Salem, North Carolina 27103, United States
ID Clinical Research, Toledo, Ohio 43608, United States
Riverside Methodist Hospital, Columbus, Ohio 43215, United States
Wright State University/Veterans Affairs Medical Center, Dayton, Ohio 45428, United States
The Reading Hospital and Medical Center, West Reading, Pennsylvania 19610, United States
St. Luke's Hospital, Bethlehem, Pennsylvania 19015, United States
Additional Information
Starting date: January 2005
Ending date: May 2006
Last updated: May 21, 2007
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