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Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358202
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : October 31, 2007
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
CPL Associates

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: cefepime Drug: ceftriaxone Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia
Study Start Date : March 2002
Actual Study Completion Date : April 2006

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 cefepime Drug: cefepime
cefepime hydrochloride 1gm IM q24h
Active Comparator: 2 ceftriaxone Drug: ceftriaxone
ceftriaxone 1 gm IM q24h


Outcome Measures
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Primary Outcome Measures :
  1. Total cost of all antibiotics. [ Time Frame: 7-14 days ]

Secondary Outcome Measures :
  1. Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs. [ Time Frame: 7-14 days ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358202


Locations
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United States, New York
CPL Associates,LLC
Buffalo, New York, United States, 14226
Sponsors and Collaborators
CPL Associates
Elan Pharmaceuticals
Investigators
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Principal Investigator: Joseph A Paladino, PharmD CPL Associates, LLC
More Information
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ClinicalTrials.gov Identifier: NCT00358202    
Other Study ID Numbers: NUR0300202A
First Posted: July 31, 2006    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by CPL Associates:
intramuscular antibiotics
nursing home acquired pneumonia
nhap
 pharmacoeconomics
cefepime
ceftriaxone
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Ceftriaxone
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents