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Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
cefepime
ceftriaxone
Sponsored by
CPL Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring intramuscular antibiotics, nursing home acquired pneumonia, nhap, pharmacoeconomics, cefepime, ceftriaxone

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CPL Associates,LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 cefepime

2 ceftriaxone

Arm Description

Outcomes

Primary Outcome Measures

Total cost of all antibiotics.

Secondary Outcome Measures

Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.

Full Information

First Posted
July 27, 2006
Last Updated
October 29, 2007
Sponsor
CPL Associates
Collaborators
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00358202
Brief Title
Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia
Official Title
Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CPL Associates
Collaborators
Elan Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
intramuscular antibiotics, nursing home acquired pneumonia, nhap, pharmacoeconomics, cefepime, ceftriaxone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 cefepime
Arm Type
Active Comparator
Arm Title
2 ceftriaxone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
cefepime
Intervention Description
cefepime hydrochloride 1gm IM q24h
Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Intervention Description
ceftriaxone 1 gm IM q24h
Primary Outcome Measure Information:
Title
Total cost of all antibiotics.
Time Frame
7-14 days
Secondary Outcome Measure Information:
Title
Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.
Time Frame
7-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Paladino, PharmD
Organizational Affiliation
CPL Associates, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPL Associates,LLC
City
Buffalo
State/Province
New York
ZIP/Postal Code
14226
Country
United States

12. IPD Sharing Statement

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Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia

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