Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
Information source: CPL Associates
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia
Intervention: cefepime (Drug); ceftriaxone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: CPL Associates Official(s) and/or principal investigator(s): Joseph A Paladino, PharmD, Principal Investigator, Affiliation: CPL Associates, LLC
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.
Clinical Details
Official title: Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Total cost of all antibiotics.
Secondary outcome: Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.
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.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
CPL Associates,LLC, Buffalo, New York 14226, United States
Additional Information
Starting date: March 2002
Last updated: October 29, 2007
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