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Standardising neonatal and paediatric antibiotic clinical trial design and conduct: the PENTA-ID network view

Laura Folgori1,2, Irja Lutsar3, Joseph F Standing4,5

  • 1Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, London, UK lfolgori@sgul.ac.uk.

BMJ Open
|January 2, 2020
PubMed

Insights

Developing new antibiotics for children faces hurdles in clinical trials (CTs). This work proposes harmonized criteria for pediatric antibiotic CTs to improve study design and data comparison.

Area of Science:

  • Pediatric Pharmacology
  • Clinical Trial Design
  • Infectious Diseases

Background:

  • Conducting randomized clinical trials (CTs) for pediatric antimicrobial development is challenging.
  • Heterogeneity in current pediatric antibiotic study design hinders comparative analysis and meta-analyses.

Purpose of the Study:

  • To propose harmonized criteria for the design and conduct of pediatric antibiotic clinical trials.
  • To adapt existing adult European Medicines Agency (EMA) guidance for neonates and children.

Main Methods:

  • A working group involving academic, regulatory, and industry representatives was formed.
  • Suggestions are based on EMA adult guidance, adapted for pediatric populations.
  • Key areas addressed include standardized inclusion/exclusion criteria, outcome measures, safety reporting, and sample sizes for safety studies.

Main Results:

  • Suggested guidance on harmonizing regulatory and strategic trials for pediatric antibiotic efficacy and safety.
  • Specific criteria for inclusion/exclusion, outcome measures for clinical infectious syndromes (CIS), safety reporting, and sample sizes were developed.
  • The proposed criteria aim for applicability in both regulatory and investigator-led trials.

Conclusions:

  • The suggested criteria provide a basis for harmonizing the design and conduct of pediatric antibiotic CTs.
  • Further international discussion with stakeholders is planned to refine these criteria.
  • Implementation of these harmonized criteria could advance antimicrobial development for children.

Keywords:
antibioticsclinical trialspaediatrics

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