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Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
This study has been completed.
Study NCT00358202   Information provided by CPL Associates
First Received: July 27, 2006   Last Updated: October 29, 2007   History of Changes

July 27, 2006
October 29, 2007
March 2002
 
Total cost of all antibiotics. [ Time Frame: 7-14 days ]
Total cost of all antibiotics.
Complete list of historical versions of study NCT00358202 on ClinicalTrials.gov Archive Site
Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. [ Time Frame: 7-14 days ]
Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.
 
Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Pneumonia
  • Drug: cefepime
  • Drug: ceftriaxone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
69
April 2006
 

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.

Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00358202
 
NUR0300202A
CPL Associates
Elan Pharmaceuticals
Principal Investigator: Joseph A Paladino, PharmD CPL Associates, LLC
CPL Associates
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP