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| Sponsor: | CPL Associates |
|---|---|
| Collaborator: |
Elan Pharmaceuticals |
| Information provided by: | CPL Associates |
| ClinicalTrials.gov Identifier: | NCT00358202 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia |
| Enrollment: | 69 |
| Study Start Date: | March 2002 |
| Study Completion Date: | April 2006 |
| Arms | Assigned Interventions |
|---|---|
| 1 cefepime: Active Comparator |
Drug: cefepime
cefepime hydrochloride 1gm IM q24h
|
| 2 ceftriaxone: Active Comparator |
Drug: ceftriaxone
ceftriaxone 1 gm IM q24h
|
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 |
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| United States, New York | |
| CPL Associates,LLC | |
| Buffalo, New York, United States, 14226 | |
| Principal Investigator: | Joseph A Paladino, PharmD | CPL Associates, LLC |
More Information
| Study ID Numbers: | NUR0300202A |
| Study First Received: | July 27, 2006 |
| Last Updated: | October 29, 2007 |
| ClinicalTrials.gov Identifier: | NCT00358202 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
intramuscular antibiotics nursing home acquired pneumonia nhap |
pharmacoeconomics cefepime ceftriaxone |
|
Anti-Infective Agents Anti-Bacterial Agents Cefepime Respiratory Tract Infections Respiratory Tract Diseases |
Therapeutic Uses Lung Diseases Ceftriaxone Pharmacologic Actions Pneumonia |