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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: AstraZeneca
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftaroline fosamil; Ceftriaxone; Cephalosporins; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• Male or female, 2 months to < 18 years old.

• Presence of CABP requiring hospitalization and IV antibacterial therapy

Exclusion Criteria:

• Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.

• Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.

• Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.

• Non-infectious causes of pulmonary infiltrates.