Pneumonia
Conditions
Keywords
intramuscular antibiotics, nursing home acquired pneumonia, nhap, pharmacoeconomics, cefepime, ceftriaxone
Brief 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.
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.
Interventions
DRUGcefepime
cefepime hydrochloride 1gm IM q24h
DRUGceftriaxone
ceftriaxone 1 gm IM q24h
Sponsors
Elan Pharmaceuticals
CPL Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total cost of all antibiotics. | 7-14 days |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. | 7-14 days |
Countries
United States
Outcome results
None listed