Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria

A Compassionate Use Protocol for Intravenous Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria That Cannot be Adequately Treated With Currently Available Therapy

The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.

Main Inclusion Criteria:

• Infection caused by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, or Enterococcus faecium that requires inpatient hospitalization and treatment with injectable antibiotics**
• Site of infection: complicated skin and skin structure infection; urinary tract infection; intra-abdominal infection; infective endocarditis; or bloodstream infection (including catheter-related).
• Pathogen resistant to, or patient intolerant of: beta-lactams, vancomycin, quinupristin/dalfopristin, or linezolid.
• Unable to receive any other standard commercially available antibacterial therapy for the infection.

Main Exclusion Criteria:

• Creatinine clearance less than 40 mL/min**
• Hemodialysis or peritoneal dialysis
• Admitted to the hospital for drug overdose or other conditions associated with rhabdomyolysis, or is expected to require repeated intramuscular injections
• Creatine phosphokinase (CPK) level greater than 2.5 times above the upper limit of normal (ULN) at screening; if the elevation in CPK can be attributed to an obvious cause (eg, surgery)**
• Central nervous system infection
• Pulmonary infection.

(**) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.