Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

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

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: AstraZeneca
• Treatments: Ceftaroline fosamil; Ceftriaxone; Cephalosporins; Methicillin; Vancomycin

Criteria

Inclusion Criteria:

• Subjects are required to meet All of the following inclusion criteria:

1. Male or female, ≥ 18 years old

2. Presence of CABP requiring hospitalization

3. Presence of CABP meeting the following criteria:

I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection

MRSA Risk Factors

• MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA

Exclusion Criteria:

• Subjects must Not meet any of the following exclusion criteria at baseline:

1. History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial

2. Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs

3. Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)

4. More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization

5. End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis

6. Evidence of significant hepatic, hematological, or immunocompromising condition