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Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia | Clinical Trials | Clareo Health

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Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia

A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia

NCT01666743•Forest Laboratories

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital.

Detailed Description

This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age) with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A switch to oral treatment may be allowed at the discretion of the Investigator. The total duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female ≥ 65 years of age.
•2. Presence of CABP warranting hospitalization.
•3. Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection.
•4. Radiographically confirmed pneumonia.

Exclusion Criteria

•1. History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent.
•2. Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen.
•3. More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment.
•4. Life expectancy of \< 30 days or presence of an order of Do Not Resuscitate (DNR).
•5. Evidence of significant hematologic, hepatic, or immunologic impairment.

Key Dates

Start Date

November 1, 2012

Primary Completion Date

September 1, 2013

Completion Date

March 1, 2014

Last Updated

February 11, 2013

Conditions

Community-Acquired Bacterial Pneumonia (CABP)

Interventions

Ceftaroline fosamil

DRUG

Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia

NCT01198626

Community-Acquired Bacterial Pneumonia (CABP)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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