Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)



Status:Completed
Conditions:Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 18
Updated:4/21/2016
Start Date:October 2012
End Date:August 2014

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A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)

This is a study of safety and effectiveness of ceftaroline fosamil in children with
Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in
pediatric subjects ages 2 months to < 18 years who are initially hospitalized with
Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to
methicillin-resistant Staphylococcus aureus (MRSA)

Inclusion Criteria:

- Presence of CABP warranting 3 days of initial hospitalization

- Confirmed presence of indicators of complicated CABP

Exclusion Criteria:

- Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial

- Confirmed or suspected infection with a pathogen known to be resistant to IV study
drugs or known infection at baseline with a sole atypical organism

- Confirmed or suspected respiratory tract infection attributable to sources other than
community acquired bacterial pneumonia

- Non-infectious causes of pulmonary infiltrates
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