MedDataX Logo

Cefepime vs. Ceftriaxone to Treat Nursing Home-Acquired Pneumonia

NCT ID: NCT00358202

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

intramuscular antibiotics nursing home acquired pneumonia nhap pharmacoeconomics cefepime ceftriaxone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 cefepime

Group Type ACTIVE_COMPARATOR

cefepime

Intervention Type DRUG

cefepime hydrochloride 1gm IM q24h

2 ceftriaxone

Group Type ACTIVE_COMPARATOR

ceftriaxone

Intervention Type DRUG

ceftriaxone 1 gm IM q24h

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cefepime

cefepime hydrochloride 1gm IM q24h

Intervention Type DRUG

ceftriaxone

ceftriaxone 1 gm IM q24h

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Elan Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

CPL Associates

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph A Paladino, PharmD

Role: PRINCIPAL_INVESTIGATOR

CPL Associates, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CPL Associates,LLC

Buffalo, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NUR0300202A

Identifier Type: -

Identifier Source: org_study_id