Pneumonia Clinical Trial
Official title:
Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia
Verified date | October 2007 |
Source | CPL Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | April 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | CPL Associates,LLC | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
CPL Associates | Elan Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total cost of all antibiotics. | 7-14 days | ||
Secondary | Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. | 7-14 days |
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