Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
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Lead
Forest Laboratories
With
AstraZeneca
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
6. Evidence of significant hepatic, hematological, or immunocompromising condition
Clareo Health | Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
