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

Sponsored by Cerexa, Inc.

Phase Quota
Phase 4

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

Study Start Date: October 2012

Estimated Completion Date: August 2014

Specialties: Pediatrics: Clinical Pharmacology,Pediatric Pulmonology,Peds Infectious Disease Infectious Disease: Antimicrobials,Peds Infectious Disease,Pulm/Thoracic Infections Pulmonology: Clinical Pharmacology,Peds Pulmonology,Pulm/Thoracic Infections Pharmacy: Antimicrobials,Drug Trials Hospitalist:


  • Drug: Ceftaroline fosamil
  • Drug: IV Ceftriaxone and Vancomycin

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

Study Locations And Contact Information

  • Investigational Site, Long Beach California

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