NCT02424734

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

Open-label, Multicentre Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Ceftaroline In Neonates And Young Infants With Late-onset Sepsis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 7 Days – 59 Days
• Healthy volunteers: Not accepted

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

Detailed description

This is a multicentre, multinational, open-label, single treatment arm study of intravenous (IV) ceftaroline fosamil and ampicillin, plus an optional aminoglycoside of choice, in hospitalized neonates and young infants aged 7 to \< 60 days with late-onset sepsis (LOS). Baseline assessments for study eligibility will occur within 36 hours before administration of the first dose of study therapy. Study Day 1 is defined as the 24-hour period starting at the onset of the first administration of study therapy. Thereafter, subsequent Study Days are to follow the same pattern. Safety assessments will occur throughout the study. Clinical outcome evaluations will occur at End-of-Therapy (EOT; within 24 hours after completion of last infusion) and Test-of-Cure (TOC; 8 to 15 days after the last dose of study therapy).

Conditions

• Late-onset Sepsis

Interventions

Type	Name	Description
DRUG	Ceftaroline Fosamil	Ceftaroline fosamil will be given at a dose of 6 mg/kg IV over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour).
DRUG	Ampicillin	Ampicillin IV is required for the first 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Will be given as per local standard of care.
DRUG	Aminoglycoside	Optional, will be given as per local standard of care.

Timeline

• Start date: 2015-08-04
• Primary completion: 2017-12-26
• Completion: 2017-12-26
• First posted: 2015-04-23
• Last updated: 2018-09-13
• Results posted: 2018-07-17

Locations

4 sites across 2 countries: United States, Hungary

Regulatory

• FDA-regulated drug study