Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

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

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.

Inclusion Criteria:

• Subject must be between the ages of 18 and 80, inclusive
• Subject must have a diagnosis of prosthetic joint infection (PJI) in a hip or knee joint which has never previously been totally revised because of an infection and for which they are anticipated to undergo a two-stage replacement surgery
• Subject must have a positive microbiological identifier of staphylococci.
• If Subject is female of childbearing potential, must be willing to practice reliable birth control

Exclusion Criteria:

• Subject has permanent intravascular prosthetic material such as heart valves or pacemakers
• Subject has a creatinine clearance (CLCR) <30 mL/min as determined by the Cockcroft-Gault equation using actual body weight.
• Subject has significant hepatic dysfunction
• Subject has a fungal or mycobacterial PJI
• Subject is known to be HIV-infected with CD4 count ≤ 200 cells/ mm3
• Subject has an abnormal creatine phosphokinase (CPK) (elevated CPK level ≥ 2x ULN) at baseline as measured by central laboratory
• Subject is currently under treatment with chemotherapeutic agents excluding chronic maintenance therapy (e.g. tamoxifen to prevent relapse of primary breast cancer)
• Subject is pregnant, nursing, or lactating.
• Subject is receiving or is expected to receive chronic immunosuppressive therapy during the study.