The SNIP-AFRICA General Assembly meeting was held from 27-28 March 2025, in Dar Es Salaam, Tanzania, bringing together representatives from 12 institutions across Africa and Europe, delegates from the Bill & Melinda Gates Foundation, Shionogi and the African Neonatal Association. The SNIP-AFRICA project aims to establish a clinical research network to tackle questions around antibiotic management of neonatal sepsis in Africa, in a time of rising antimicrobial resistance. Using an innovative approach, SNIP-AFRICA aims to improve the way severe infections in newborns are treated.
As the project progresses, the discussions at the assembly set an optimistic tone for the future. A key milestone is the upcoming launch of the NeoSep1 trial in Africa, set to commence in April 2025. With site initiation visits performed in January 2025, the first two South African sites (Tygerberg Hospital in Cape Town and Chris Hani Baragwanath Hospital in Johannesburg) are ready to kick off trial activities, followed by six additional sites across Ghana, Kenya and Uganda. NeoSep1 is a groundbreaking clinical trial utilising an innovative design to empirically compare multiple antibiotic regimens, with the goal of identifying the most effective treatments for neonatal sepsis. Findings from this trial hold the potential to inform future World Health Organization guidelines on neonatal sepsis management.
Beyond NeoSep1, the assembly highlighted remarkable progress across various project components:
- Surveillance activities: A comprehensive system for the clinical and microbiological surveillance of neonatal infections, antimicrobial resistance colonisation prevalence and antibiotic prescribing trends was successfully established. Surveillance activities will be conducted in five African countries, aiming to generate critical insights into how newborns hospitalised with sepsis are managed. The data collected will help inform best practices and optimise treatment strategies.
- Pharmacokinetics (PK) research: The pharmacokinetics team has made significant progress in developing standard templates for study protocols, electronic case report forms (eCRFs) and pharmacometrics analysis plans for antimicrobial neonatal and infant PK studies. These templates adhere to rigorous regulatory and ethical standards and can be adapted for both dose confirmation and dose-finding studies. Additionally, the PRECISION study is underway, with six infants already enrolled to evaluate the optimal dosing of colistin. These findings will contribute to safer and more effective antimicrobial therapy for neonatal sepsis.
- Stakeholder engagement: The project team has actively engaged with diverse stakeholders through meetings, workshops and focus groups. Participants included regulators, ethics committee representatives, parent groups, clinicians and midwives. Discussions centred on strategies to establish and maintain parent support groups, as well as addressing concerns and preferences regarding the administration of informed consent forms for enrolling newborns in complex clinical trials. This engagement is crucial for fostering trust and ensuring ethical research practices that align with community needs and expectations.
- Capacity Building & Training: The SNIP-AFRICA Training and Capacity Building platform was launched, designed to support site staff across the Consortium in acquiring expertise in neonatal sepsis management, good clinical practice, and other essential aspects of clinical trial management. The enthusiasm surrounding this initiative highlighted its potential to improve clinical trial management in resource-limited settings. Participants also provided valuable input on expanding the training curriculum to include additional courses in the future.
Overall, the General Assembly was a great success. Partners left the meeting feeling energised and optimistic about the contribution that the SNIP-AFRICA project can make in the management of sepsis in hospitalised newborns.
Read the press release by Penta and Ifakara Health Institute, Tanzania, who hosted the General Assembly.
