Conditions: Osteomyelitis
Keywords: Osteomyelitis Prosthetic Hip Prosthetic Knee MRSA Osteomyelitis Associated with an Infected Prosthetic Hip or Knee Joint Staphylococci
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Daptomycin (6 mg/kg every 24 hours \[q24h\]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week). arm 2: Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week). arm 3: Vancomycin was administered at 1 gram every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).

Interventions: intervention 1: daptomycin intervention 2: daptomycin intervention 3: vancomycin intervention 4: teicoplanin intervention 5: nafcillin intervention 6: oxacillin intervention 7: flucloxacillin
Intervention descriptions: intervention 1: 6 mg/kg intervention 2: 8 mg/kg intervention 3: 1 gram intervention 4: 6 mg/kg; used only at UK sites intervention 5: 1-2 gram intervention 6: 1-2 gram intervention 7: 1-2 mg

Protocol document: