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

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-03-31

Brief Summary

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

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

NCT01605864

Community Acquired Bacterial Pneumonia

COMPLETED PHASE3

Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

NCT00509106

Bacterial Pneumonia

COMPLETED PHASE3

A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia

NCT01371838

Community-Acquired Bacterial Pneumonia Lung Infection of Individual Not Recently Hospitalized

COMPLETED PHASE3

Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia

NCT01524302

Pneumonia, Bacterial Community-acquired

COMPLETED PHASE4

OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis

NCT06669403

Sepsis Community Acquired Pneumonia (CAP)

NOT_YET_RECRUITING PHASE1

Detailed Description

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

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.

Conditions

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

Community-Acquired Bacterial Pneumonia (CABP)

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Ceftaroline fosamil

IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)

Group Type EXPERIMENTAL

Ceftaroline fosamil

Intervention Type DRUG

IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)

Interventions

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

Ceftaroline fosamil

IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Teflaro® PPI-0903 TAK-599 TAK599 PPI0903

Eligibility Criteria

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

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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No