Sepsis is a life-threatening condition that occurs when the body’s response to an infection damages its own tissues and organs. In newborns, sepsis is often caused by bacteria that have become resistant to antibiotics, which makes it even more difficult to treat. Funded by the European Union under the Global Health EDCTP3 Programme, SNIP-AFRICA will conduct an adaptive trial to identify the best drug regimens and doses for difficult-to-treat infections and sepsis, which threaten the lives of newborns in neonatal units in sub-Saharan African countries.
SNIP-AFRICA will be coordinated by Fondazione Penta ETS, while St George's University of London will be responsible for scientific oversight. Professor Jay Berkley, Principal Investigator, KWTRP said: ‘KEMRI-Wellcome Trust Research Programme are delighted to participate in this consortium. Antibiotic resistance is a growing problem and a recognized major health priority in Kenya. Consequently, there are gaps in our knowledge of how best to treat newborn babies with serious infections. This study will provide the answers we need in Kenya and elsewhere in Africa as to which antibiotics are most effective.’
Every year, 214,000 newborn babies die of sepsis that has become resistant to antibiotics, making it a major health threat worldwide. Low- and middle-income countries, especially in Africa, are particularly affected by this problem due to the lack of resources for diagnosis and treatment.
What’s more, the heterogeneous nature of sepsis means that relevant research questions may vary greatly from one hospital to another, posing a challenge for traditional clinical trials to comprehensively grasp the complexities and variations of this condition, and to find treatments suitable for multiple settings.
Professor Carlo Giaquinto, Professor of Paediatrics at the University of Padova, President of Fondazione Penta ETS (Italy) and project coordinator said: ‘SNIP-AFRICA is a landmark project that will bring together leading scientists from Africa and Europe to address this major global health challenge. We believe that this project will help us identify new and better treatments for newborn sepsis, which is a leading cause of death in newborns in Africa.’
The SNIP-AFRICA trial will use an adaptive platform design, which allows researchers to adjust the trial as it progresses based on the results of early data. In comparison to traditional trial designs, adaptive platform trials can address multiple research questions simultaneously, providing a more personalised approach to researching neonatal sepsis.
Dr Julia Bielicki, Senior Researcher at the Centre for Neonatal and Paediatric Infection of St George’s University of London, and SNIP-AFRICA scientific coordinator said: ‘SNIP-AFRICA is a critical step in the fight against newborn sepsis. We are excited to see this project get underway, and we are confident that it will make a significant difference in the lives of newborns in Africa.’
SNIP-AFRICA is part of the EDCTP3 Programme supported by the European Union The trial plans to enrol 1,200 neonates in six neonatal intensive care units in Ghana, Kenya, South Africa and Uganda. The first patients are expected to be enrolled in June 2025.
To guarantee the sustainability of the SNIP-AFRICA platform, the Consortium will also invest in building the capacity of African researchers and clinicians to develop and implement future adaptive trials, fostering a culture of knowledge-sharing and collaboration. Through this project, we aspire to build a robust network of trained investigators and sites capable of designing and conducting complex clinical trials in challenging environments.
Overall, ten project partners from European and African countries will come together to constitute a diverse Consortium of partners with extensive experience in neonatology and in designing and conducting randomised controlled trials in Africa, including adaptive trials.
This project aims to innovate research on severe childhood infections, particularly neonatal sepsis. By using novel adaptive trial design elements, the project will generate evidence to improve antibiotic treatment of this deadly condition. This will significantly improve the well-being of newborns and infants, who are at the highest risk of infection from difficult-to-treat bacteria.