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Updated: May 9, 2026
14:54
A Controlled Mouse Model for Neonatal Polymicrobial Sepsis
Published on: January 27, 2019
Clinical trials in neonatal sepsis
Clarissa Oeser1, Irja Lutsar, Tuuli Metsvaht
1Paediatric Infectious Diseases Research Group, St George's, University of London, London, UK.
The Journal of Antimicrobial Chemotherapy
|August 2, 2013
Summary
Conducting antibiotic trials in neonates is challenging due to unclear sepsis definitions and endpoints. Future studies require pharmacokinetic/pharmacodynamic data and robust clinical trials for safety and efficacy.
Area of Science:
- Neonatal pharmacology
- Infectious diseases
- Clinical trial design
Background:
- Antibiotic licensing studies in neonates face significant challenges.
- Traditional adult-based trial designs are unsuitable for neonatal populations, where sepsis is prevalent.
Purpose of the Study:
- To highlight the difficulties in defining neonatal sepsis for clinical trials.
- To review existing neonatal sepsis trial designs.
- To propose an optimal framework for future neonatal antibiotic trials.
Main Methods:
- Review of clinical and laboratory definitions of neonatal sepsis.
- Analysis of designs from previous neonatal sepsis trials.
- Discussion of pharmacokinetic/pharmacodynamic (PK/PD) principles.
Main Results:
- Lack of consensus on neonatal sepsis definition and endpoints hinders trial conduct.
- Existing trials exhibit varied designs, complicating comparisons and generalizability.
- PK/PD parameters are crucial for optimizing antibiotic dosing and efficacy in neonates.
Conclusions:
- Future neonatal antibiotic trials must integrate PK/PD data with rigorous clinical evaluations.
- Standardized definitions and endpoints for neonatal sepsis are essential.
- Well-designed trials are necessary to establish safety and efficacy of new antibiotics in neonates.
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