Core Outcome Measures in Effectiveness Trials

Clinical trials in neonatal sepsis

General Information

Abstract:
Antibiotic licensing studies remain a problem in neonates. The classical adult clinical syndrome-based licensing studies do not apply to neonates, where sepsis is the most common infection. The main obstacle to conducting neonatal antibiotic trials is a lack of consensus on the definition of neonatal sepsis itself and the selection of appropriate endpoints. This article describes the difficulties of the clinical and laboratory definitions of neonatal sepsis and reviews the varying designs of previous neonatal sepsis trials. The optimal design of future trials of new antibiotics will need to be based on pharmacokinetic/pharmacodynamic parameters, combined with adequately powered clinical studies to determine safety and efficacy.

Authors:
Oeser, C. Lutsar, I. Metsvaht, T. Turner, M. A. Heath, P. T. Sharland, M.

Publication

Journal:
J Antimicrob Chemother
Volume:
68
Issue:
12
Pages:
2733 - 45
Year:
2013
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Infectious disease
Neonatal care

Disease Name
Sepsis

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Unknown

Method(s)

Unknown

Stakeholders Involved

Unknown

Study Type

Systematic review of outcomes measured in trials

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