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

• Status: Withdrawn
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Ceftaroline fosamil; Cephalosporins

Criteria

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.