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

This study has been terminated.

First Received on February 4, 2005. Last Updated on May 21, 2007 History of Changes

Sponsor:	Cubist Pharmaceuticals
Information provided by:	Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00102947

Purpose

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.

Condition	Intervention	Phase
Soft Tissue Infections	Drug: daptomycin (up to 14 days)	Phase IV

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

Resource links provided by NLM:

Drug Information available for: Daptomycin

U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	72
Study Start Date:	January 2005
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102947

Locations

United States, California
Harbor UCLA Medical Center
Torrance, California, United States, 90509
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Joseph M. Still Research Institute
Augusta, Georgia, United States
United States, Minnesota
Infectious Diseases Minneapolis-LTD
Minneapolis, Minnesota, United States, 55422
United States, New York
Upstate Clinical Research Associates
Buffalo, New York, United States, 14203
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
AllTrials Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43215
Wright State University/Veterans Affairs Medical Center
Dayton, Ohio, United States, 45428
ID Clinical Research
Toledo, Ohio, United States, 43608
United States, Pennsylvania
St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 19015
The Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19610

Sponsors and Collaborators

Cubist Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00102947 History of Changes
Other Study ID Numbers:	DAP-REN-03-06
Study First Received:	February 4, 2005
Last Updated:	May 21, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:

renal impairment
daptomycin
Cubist
complicated skin and skin structure infections

Additional relevant MeSH terms:

Soft Tissue Infections
Renal Insufficiency
Infection
Kidney Diseases
Urologic Diseases

Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012