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



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

For Condition: Gram-Positive Bacterial Infections
Status: No longer recruiting
Sponsor(s): Cubist Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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. - Be 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.
Total Enrollment: 75

Location and Contact Information:


Additional Information:
Study ID Numbers:  DAP-EAP-02-01; 
Study Start Date: January 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055198

Other Gram-Positive Bacterial Infections Studies:
1. Daptomycin for the Treatment of Infections Due to Gram-positive Bacteria

2. ARBELICâ„¢ (TD 6424) for Treatment of Uncomplicated Staphylococcus aureus Bacteremia

3. Treatment of neutropenic patients with fever who are suspected to have a gram positive infection (a specific kind of bacteria)

4. New Antibiotic to treat patients with community-acquired pneumonia due to a specific bacteria (S. pneumoniae pneumonia)

5. Antibiotic treatment for patients with infections of short term in-dwelling vascular catheters due to a specific bacteria (gram positive bacteria)

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