Neonatal sepsis is a widespread issue worldwide, and the current standard treatments are becoming less effective due to the combined challenge of high mortality rates and increasing antimicrobial resistance.
There is a need to conduct pragmatic trials that can provide valuable insights for managing neonatal infections in low and middle-income countries. Adaptive trials offer the most efficient design: these trials support adaptations and other necessary modifications to improve clinical practices and enhance the evidence base for neonatal infection management.
Severe Neonatal Infection Adaptive Platform trials in Africa
SNIP-AFRICA aims to target neonatal sepsis by establishing a clinical research network and architecture to implement adaptive platform trials in sub-Saharan Africa, responding to the urgent need for improved treatment of childhood infection in an era of increasing antimicrobial resistance.
SNIP-AFRICA will achieve its aim by bringing together partners from the global North and sub-Saharan Africa, including several partners with experience in designing and running adaptive platform trials and complex randomised controlled trials in sub-Saharan Africa. The project therefore builds on existing expertise and capacity to enable an innovative response to the major threat to child health of antimicrobial resistance through a new architecture and extended network.
Ultimately, SNIP-AFRICA aims to trigger a paradigm shift in interventional research in severe childhood infection and to equip a network of sub-Saharan African institutions and researchers to conduct innovative, efficient, targeted research in this area.
What are SNIP-AFRICA’s goals?
The project’s goals are:
To create a sustainable platform, spanning the global North and sub-Saharan Africa, to conduct adaptive trials for treating severe childhood infections
To implement an adaptive trial to determine the best antibiotic regimens for the treatment of infants with neonatal sepsis in sub-Saharan Africa within the ‘drug-regimen’ domain
To conduct up to two pharmacokinetic studies within the ‘dose domain’ to support incorporation of antibiotics of interest at optimal neonatal doses into the platform
To collect data on current clinical management, healthcare utilisation and bacterial epidemiology among hospitalised infants with neonatal sepsis
To provide training opportunities on conducting adaptive platform trials to researchers and clinicians in sub-Saharan Africa
To involve community representatives, clinicians, and regulators to ensure efficient and ethical implementation of adaptive trials through the platform.
What will SNIP-AFRICA do?
The SNIP-AFRICA project (101103201) is supported by the Global Health EDCTP3 and its members (the European Union and the EDCTP Association).