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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00102947
First received: February 4, 2005
Last updated: July 22, 2016
Last verified: July 2016

February 4, 2005
July 22, 2016
January 2005
November 2006   (final data collection date for primary outcome measure)
To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment
Same as current
Complete list of historical versions of study NCT00102947 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Soft Tissue Infections
Drug: daptomycin (up to 14 days)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
November 2006
November 2006   (final data collection date for primary outcome measure)
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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102947
3009-020, DAP-REN-03-06
Not Provided
Not Provided
Not Provided
Cubist Pharmaceuticals LLC
Cubist Pharmaceuticals LLC
Not Provided
Not Provided
Cubist Pharmaceuticals LLC
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP