Viewing Study NCT00358202



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Study NCT ID: NCT00358202
Status: COMPLETED
Last Update Posted: 2007-10-31
First Post: 2006-07-27

Brief Title: Cefepime vs Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
Sponsor: CPL Associates
Organization: CPL Associates

Study Overview

Official Title: Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia
Status: COMPLETED
Status Verified Date: 2007-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None