Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

Phase 2 Terminated 11 enrolled Pfizer PRA Health Sciences · collab

Open-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the treatment of Late Onset Sepsis in neonates and young infants aged 7 to \<60 days

Timeline

Start: 2015-08-04
Primary completion: 2017-12-26
Completion: 2017-12-26

Publications

Bradley JS, Stone GG, Chan PLS, Raber SR, Riccobene T, Mas Casullo V, Yan JL, Hendrick VM, Hammond J, Leister-Tebbe HK. Phase 2 Study of the Safety, Pharmacokinetics and Efficacy of Ceftaroline Fosamil in Neonates and Very Young Infants With Late-onset Sepsis. Pediatr Infect Dis J. 2020 May;39(5):411-418. doi: 10.1097/INF.0000000000002607.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftaroline fosamil	Other / unclassified	4 mg/kg	Intravenous
Subject	Ceftaroline fosamil	Other / unclassified	6 mg/kg	Intravenous
Background	Ampicillin	Unknown	—	Intravenous

Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

Summary

Timeline

Publications

Drugs

Indications