Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria
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ClinicalTrials.gov Identifier: NCT00055198
(Study terminated due to low enrollment)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
(**) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.