We are pleased to announce the publication of “Standardising neonatal and paediatric antibiotic clinical trial design and conduct: the PENTA-ID network view” in the BMJ, by our friends Laura Folgori, Irja Lutsar, Sarah Walker, Mike Sharland.
This article offers the Penta ID network view on the general principles for harmonisation between regulatory and strategic trials. These include:
- Standardised key inclusion/ exclusion criteria and widely applicable outcome measures for specific clinical infectious syndromes to be used in clinical trials on efficacy of antibiotic in children
- Key components of safety that should be reported in paediatric antibiotic clinical trials
- Standardised sample sizes for safety studies.
Summarising views from a range of stakeholders, this article specifies recommended criteria for the design and conduct of efficacy and safety antibiotic trials in specific clinical infectious syndromes for children have been developed. These criteria can be used for the harmonisation in the design and conduct of clinical trials on antibiotics in children.
Read the full article here: https://penta-id.org/category/publications/antimicrobials/