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

• Status: Completed
• Trial end date: 2010-06-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Daptomycin; Floxacillin; Nafcillin; Oxacillin; Teicoplanin; Vancomycin

Criteria

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.