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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 27, 2006 | ||||
| Last Updated Date | October 29, 2007 | ||||
| Start Date ICMJE | March 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Total cost of all antibiotics. [ Time Frame: 7-14 days ] | ||||
| Original Primary Outcome Measures ICMJE |
Total cost of all antibiotics. | ||||
| Change History | Complete list of historical versions of study NCT00358202 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. [ Time Frame: 7-14 days ] | ||||
| Original Secondary Outcome Measures ICMJE |
Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia | ||||
| Official Title ICMJE | Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia | ||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Pneumonia | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 69 | ||||
| Completion Date | April 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00358202 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NUR0300202A | ||||
| Study Sponsor ICMJE | CPL Associates | ||||
| Collaborators ICMJE | Elan Pharmaceuticals | ||||
| Investigators ICMJE |
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| Information Provided By | CPL Associates | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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