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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftaroline fosamil; Ceftriaxone; Cephalosporins; Clavulanic Acid; Clavulanic Acids; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Linezolid; Vancomycin

Criteria

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