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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102947
Recruitment Status : Terminated
First Posted : February 7, 2005
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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.

Condition or disease Intervention/treatment Phase
Soft Tissue Infections Drug: daptomycin (up to 14 days) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin




Primary Outcome Measures :
  1. 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 :
  1. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102947


Locations
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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 LLC

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Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00102947    
Other Study ID Numbers: 3009-020
DAP-REN-03-06 ( Other Identifier: Cubist Study Number )
First Posted: February 7, 2005    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Keywords provided by Cubist Pharmaceuticals LLC:
renal impairment
daptomycin
Cubist
complicated skin and skin structure infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Soft Tissue Infections
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Skin Diseases
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents