Late-onset Sepsis Clinical Trial
Official title:
Open-label, Multicentre Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Ceftaroline In Neonates And Young Infants With Late-onset Sepsis
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
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).
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