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

• ClinicalTrials.gov Identifier: NCT00102947
• Recruitment Status: Terminated
• First Posted: February 7, 2005
• Last Update Posted: July 25, 2016
• Sponsor: Cubist Pharmaceuticals LLC
• Information provided by (Responsible Party): Cubist Pharmaceuticals LLC

Tracking Information

• First Submitted Date: February 4, 2005
• First Posted Date: February 7, 2005
• Last Update Posted Date: July 25, 2016
• Study Start Date: January 2005
• Actual Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2005): To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 23, 2005): 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
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Soft Tissue Infections
• Intervention: Drug: daptomycin (up to 14 days)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: June 23, 2005): 72
• Original Enrollment: Same as current
• Actual Study Completion Date: November 2006
• Actual Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
• Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00102947
• Other Study ID Numbers: 3009-020; DAP-REN-03-06 ( Other Identifier: Cubist Study Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Cubist Pharmaceuticals LLC
• Study Sponsor: Cubist Pharmaceuticals LLC
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cubist Pharmaceuticals LLC
• Verification Date: July 2016