Gram-Positive Bacterial Infections
Conditions
Keywords
Gram positive bacterial infections, expanded access program, resistant infections, bacteremia, Bacterial and fungal infections, bacterial infections
Brief summary
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.
Interventions
DRUGdaptomycin
Sponsors
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Outcome results
None listed