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OpenTrials
Completed

NCT Number: NCT00358202

Cefepime vs. Ceftriaxone to Treat 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CPL Associates,LLC

Buffalo, New York, 14226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefepime

Drug

cefepime hydrochloride 1gm IM q24h

Ceftriaxone

Drug

ceftriaxone 1 gm IM q24h

Primary outcomes

  1. Total cost of all antibiotics.

    Time frame: 7-14 days

Secondary outcomes

  1. Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.

    Time frame: 7-14 days

Sponsors and collaborators

Lead sponsor

CPL Associates

Other

Collaborators

  • Elan Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Jul 31, 2006
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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