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