NCT00102947

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (planned)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Infections

Interventions

Type	Name	Description
DRUG	daptomycin (up to 14 days)

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-02-07
• Last updated: 2016-07-25

Locations

12 sites across 1 country: United States