Clinical trials in neonatal sepsis

J Antimicrob Chemother. 2013 Dec;68(12):2733-45. doi: 10.1093/jac/dkt297. Epub 2013 Jul 30.


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.

Keywords: antibiotics; endpoints; infants; methodology.

Publication types

  • Review

MeSH terms

  • Anti-Bacterial Agents / therapeutic use*
  • Clinical Trials as Topic / standards*
  • Endpoint Determination / standards
  • Humans
  • Infant, Newborn
  • Sepsis / diagnosis*
  • Sepsis / drug therapy*
  • Terminology as Topic
  • Treatment Outcome


  • Anti-Bacterial Agents