Status:
COMPLETED
Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
Lead Sponsor:
CPL Associates
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Pneumonia
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime is a safe, efficacious, and cost-effective alternative to once daily intramuscular ceftriaxone for the tre...
Detailed Description
To compare the efficacy, safety, and pharmacoeconomics of cefepime versus ceftriaxone. Double-blind study of nursing home residents \>60 years of age with pneumonia. Patients were randomized to cefepi...
Eligibility Criteria
Inclusion
- Residents of a nursing home for \>=30 days who were at least 60 years of age and developed pneumonia not amenable to oral antibiotics while not requiring hospitalization, a new infiltrate on chest Xray, estimated Clcr \<=60 mL/min, presence of standard clinical criteria, signed informed consent.
Exclusion
- Allergy to cephalosporins, receipt of \>24 hours of an antibiotic (unless no improvement was evident), an existing infection due to a pathogen known resistant to either study drug; expected mortality within 48 hours, immunosuppression, hypotension or respiratory distress requiring ventilatory support, prior limited treatment or supportive care only directives, suspected or known Pseudomonas aeruginosa or MRSA infections, primary lung cancer or another malignancy metastatic to the lungs, bronchial obstruction or a history of post-obstructive pneumonia, or patients receiving renal dialysis.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00358202
Start Date
March 1 2002
End Date
April 1 2006
Last Update
October 31 2007
Active Locations (1)
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1
CPL Associates,LLC
Buffalo, New York, United States, 14226