Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00358202
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2006-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
Sponsor:
CPL Associates
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: