drugset / Trial / NCT01669980

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

NCT01669980

Phase 4 Completed 40 enrolled Forest Laboratories
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2012-10
Primary completion
2014-05
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftaroline fosamil Other / unclassified 10 mg/kg Intravenous
Subject Ceftaroline fosamil Other / unclassified 15 mg/kg Intravenous
Subject Ceftaroline fosamil Other / unclassified 600 mg Intravenous
Comparator Ceftriaxone Other / unclassified 75 mg/kg Intravenous
Comparator Vancomycin Other / unclassified 15 mg/kg Intravenous
Background Amoxicillin Other / unclassified 45 mg/kg Oral
Background Amoxicillin Other / unclassified 90 mg/kg Oral
Background Clindamycin Unknown 13 mg/kg Oral
Background Linezolid Other / unclassified 10 mg/kg Oral
Background Linezolid Other / unclassified 600 mg Oral

Indications