Aug 2, 2013

Clinical trials in neonatal sepsis

The Journal of Antimicrobial Chemotherapy
Clarissa OeserMike Sharland

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.

  • References31
  • Citations10

References

  • References31
  • Citations10

Citations

Mentioned in this Paper

Septicemia
Bacterial Sepsis of Newborn
Antibiotic throat preparations
Antifungal Antibiotics, Topical
Endpoint Determination
Antibiotics, Gynecological
Pharmacodynamics
Sepsis of the Newborn
Clinical Trials
Antibiotics for systemic use

Related Feeds

Antifungals (ASM)

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.

Antifungals

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.