Study:
A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthetic Hip or Knee Joint Caused by Staphylococci
Rationale:
n/a
Purpose:
This is a research study designed to look at the efficacy and safety of daptomycin given at
a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections
caused by Staphylococci. These types of bacteria are among the most common types of bacteria
causing infections of prosthetic joints.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Osteomyelitis |
Drug: daptomycin Drug: daptomycin Drug: vancomycin Drug: teicoplanin Drug: nafcillin Drug: oxacillin Drug: flucloxacillin |
Phase 2 |
Verified by
Cubist Pharmaceuticals
May, 2011
Sponsored by: Cubist Pharmaceuticals
Information provided by: Cubist Pharmaceuticals
ClinicalTrials.gov identifier: NCT00428844
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
Alistair Wheeler, MD., Study Director