Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
- Registration Number
- NCT00358202
- Lead Sponsor
- CPL Associates
- 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 treatment of elderly nursing home residents who develop pneumonia and do not require hospitalization.
- 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 cefepime or ceftriaxone 1 gm q24h to be administered intramuscularly. After three days, responding patients could be switched to oral antibiotics. Main Outcome Measures: clinical success, adverse events, and cost-effectiveness ratios.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 cefepime cefepime - 2 ceftriaxone ceftriaxone -
- Primary Outcome Measures
Name Time Method Total cost of all antibiotics. 7-14 days
- Secondary Outcome Measures
Name Time Method Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. 7-14 days
Trial Locations
- Locations (1)
CPL Associates,LLC
🇺🇸Buffalo, New York, United States