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

Forest Laboratories

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Community-Acquired Bacterial Pneumonia (CABP)

Interventions

Ceftaroline fosamilDRUG

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)

Safety evaluations will be conducted and assessments will include: * Adverse events including deaths will be evaluated. * Laboratory: complete blood count with differential, and chemistry panel.

Time frame: Between 3 and 33-37 days

Secondary Outcomes

Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)

Efficacy outcome measures: * Time to clinical stability * Length of stay * Clinical outcome at End-of-Intravenous Study Drug, End-of-Therapy, and Test-of-Cure * Mortality * 30-day readmission

Time frame: 30 days following discharge from the hospital, anticipated between 33 to 37 days.

Data from ClinicalTrials.gov

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