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

Phase 2/3 Completed 161 enrolled Forest Laboratories AstraZeneca · collab

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2012-09
Primary completion: 2014-04
Completion: 2014-07

Publications

Cannavino CR, Nemeth A, Korczowski B, Bradley JS, O'Neal T, Jandourek A, Friedland HD, Kaplan SL. A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline Versus Ceftriaxone. Pediatr Infect Dis J. 2016 Jul;35(7):752-9. doi: 10.1097/INF.0000000000001159.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftaroline fosamil	Other / unclassified	8 mg/kg	Intravenous
Subject	Ceftaroline fosamil	Other / unclassified	12 mg/kg	Intravenous
Subject	Ceftaroline fosamil	Other / unclassified	400 mg	Intravenous
Comparator	Ceftriaxone	Other / unclassified	75 mg/kg	Intravenous
Comparator	Ceftriaxone	Other / unclassified	4 g	Intravenous
Background	Amoxicillin	Other / unclassified	90 mg/kg	Oral

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

Summary

Timeline

Publications

Drugs

Indications