Severe neonatal infection adaptive platform trials in Africa

SNIP-AFRICA aims to establish a clinical research network and architecture to implement adaptive platform trials in sub-Saharan Africa (SSA), responding to the urgent need for improved treatment of childhood infection in an era of increasing antimicrobial resistance (AMR).

SNIP-AFRICA focuses on the high-burden, high-impact group of inpatient neonates and infants with sepsis. This is a group especially affected by escalating rates of AMR in SSA healthcare facilities contributing to much slower than desirable improvements in neonatal mortality across SSA.

The project will address all aspects of APTs in neonatal sepsis from defining potential treatments of interest to translation into clinical guidance, and will deliver interventional studies in the two domains of neonatal dose confirmation and drug regimen selection. The network and architecture could be readily extended to include older children in hospital with infections with epidemic potential.

SNIP-AFRICA will achieve its aim by bringing together partners from the global North and SSA, including several with experience in designing and running adaptive platform trials and complex randomised controlled trials in SSA. The project therefore builds on existing expertise and capacity to enable an innovative response to the major threat to child health of AMR through a new architecture and extended network. The work plan includes Project Management, Coordination and Communication (WP1), Clinical and Microbiological Surveillance (WP2), Adaptive Platform Core Protocol and Governance (WP3), Pharmacokinetics for Adaptive Platform Trial (WP4), Complex Adaptive Drug Regimen Trial (WP5), Training and Capacity building for Adaptive Trials (WP6) and Stakeholder Engagement and Integration (WP7).

SNIP-AFRICA aims to trigger a paradigm shift in interventional research in severe childhood infection and to equip a network of SSA institutions and researchers to conduct innovative, efficient, targeted research in this area.