title: Clinical trials in neonatal sepsis.
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.affiliation: Paediatric Infectious Diseases Research Group, St George's, University of London, London, UK.
authors.forename: Clarissa
authors.initials: C
authors.lastname: Oeser
authors.forename: Irja
authors.initials: I
authors.lastname: Lutsar
authors.forename: Tuuli
authors.initials: T
authors.lastname: Metsvaht
authors.forename: Mark A
authors.initials: MA
authors.lastname: Turner
authors.forename: Paul T
authors.initials: PT
authors.lastname: Heath
authors.forename: Mike
authors.initials: M
authors.lastname: Sharland
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D023381:Endpoint Determination / Q000592:standards; D006801:Humans; D007231:Infant, Newborn; D018805:Sepsis / Q000175:diagnosis* / Q000188:drug therapy*; D009626:Terminology as Topic; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents
keywords: antibiotics; endpoints; infants; methodology