Official Title: “Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: cefepime
  • cefepime hydrochloride 1gm IM q24h
• Drug: ceftriaxone
  • ceftriaxone 1 gm IM q24h

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1 cefepime
• Active Comparator: 2 ceftriaxone

Primary Measures

• Total cost of all antibiotics.
  • Time Frame: 7-14 days
    

Secondary Measures

• Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.
  • Time Frame: 7-14 days
    

• Inclusion Criteria: 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 Criteria: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: CPL Associates

Overall Clinical Trial Officials and Contacts

Joseph A Paladino, PharmD Principal Investigator CPL Associates, LLC  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00358202

Study ID Number: NUR0300202A

ClinicalTrials.gov Identifier: NCT00358202

Health Authority: United States: Institutional Review Board