Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
CPL Associates
ClinicalTrials.gov Identifier:
NCT00358202
First received: July 27, 2006
Last updated: October 29, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Pneumonia
Drug: cefepime
Drug: ceftriaxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by CPL Associates:

Primary Outcome Measures:
  • Total cost of all antibiotics. [ Time Frame: 7-14 days ]

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

Enrollment: 69
Study Start Date: March 2002
Study Completion Date: April 2006
Arms Assigned Interventions
Active Comparator: 1 cefepime Drug: cefepime
cefepime hydrochloride 1gm IM q24h
Active Comparator: 2 ceftriaxone Drug: ceftriaxone
ceftriaxone 1 gm IM q24h

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00358202

Locations
United States, New York
CPL Associates,LLC
Buffalo, New York, United States, 14226
Sponsors and Collaborators
CPL Associates
Elan Pharmaceuticals
Investigators
Principal Investigator: Joseph A Paladino, PharmD CPL Associates, LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00358202     History of Changes
Other Study ID Numbers: NUR0300202A
Study First Received: July 27, 2006
Last Updated: October 29, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by CPL Associates:
intramuscular antibiotics
nursing home acquired pneumonia
nhap
pharmacoeconomics
cefepime
ceftriaxone

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014