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

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.