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

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and
safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with
Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant
Staphylococcus aureus.

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