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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.
Details
| Lead sponsor | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 72 |
| Start date | 2005-01 |
| Completion | 2006-11 |
Conditions
- Soft Tissue Infections
Interventions
- daptomycin (up to 14 days)
Primary outcomes
- To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment
Countries
United States