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NCT00358202 Clinical Trial

Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00358202
Other study ID # NUR0300202A
Secondary ID
Status Completed
Phase Phase 4
First received July 27, 2006
Last updated October 29, 2007
Start date March 2002
Est. completion date April 2006

Study information
Verified date October 2007
Source CPL Associates
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 69
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States CPL Associates,LLC Buffalo New York

Sponsors (2)
Lead Sponsor Collaborator
CPL Associates Elan Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total cost of all antibiotics. 7-14 days
Secondary Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. 7-14 days
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