Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia

Sponsor

CPL Associates (Other)

Overall Status

Completed

CT.gov ID

NCT00358202

Collaborator

Elan Pharmaceuticals (Industry)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: cefepime Drug: ceftriaxone	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2002

Actual Study Completion Date :

Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 cefepime	Drug: cefepime cefepime hydrochloride 1gm IM q24h
Active Comparator: 2 ceftriaxone	Drug: ceftriaxone ceftriaxone 1 gm IM q24h

Arm

Intervention/Treatment

Active Comparator: 1 cefepime

Drug: cefepime

cefepime hydrochloride 1gm IM q24h

Active Comparator: 2 ceftriaxone

Drug: ceftriaxone

ceftriaxone 1 gm IM q24h

Outcome Measures

Primary Outcome Measures

Total cost of all antibiotics. [7-14 days]

Secondary Outcome Measures

Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. [7-14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.