Periodic Reporting for period 1 - SNIP-AFRICA (Severe neonatal infection adaptive platform trials in Africa)
Reporting period: 2023-07-01 to 2024-12-31
Severe neonatal infections, particularly sepsis, remain a leading cause of mortality in sub-Saharan Africa, exacerbated by the growing threat of antimicrobial resistance. The SNIP-AFRICA project—Severe Neonatal Infection Adaptive Platform Trials in Africa—addresses this urgent public health challenge by establishing a sustainable, multi-country clinical research platform to evaluate and optimise treatment strategies for neonatal sepsis.
SNIP-AFRICA’s overarching goal is to implement adaptive platform trials tailored to the sSA context, enabling continuous evaluation of multiple treatment regimens and rapid integration of new evidence. The project brings together a consortium of African and European institutions to build capacity, foster collaboration, and generate high-quality evidence to inform clinical practice and policy.
The project’s specific objectives include:
• Establishing a robust governance and operational framework for a fit-for-purpose trial platform.
• Conducting innovative clinical trials incorporating adaptative and platform elements to address antibiotic treatment of neonatal sepsis.
• Performing pharmacokinetic studies to optimise dosing of key antimicrobials to be taken forward in trials.
• Implementing real-time surveillance of neonatal sepsis and AMR trends to improve understanding of research gaps.
• Building capacity through training and stakeholder engagement, including families, clinicians, and regulators.
SNIP-AFRICA is expected to significantly improve neonatal outcomes, strengthen research capacity in sSA, and contribute to global efforts to combat AMR.
SNIP-AFRICA’s overarching goal is to implement adaptive platform trials tailored to the sSA context, enabling continuous evaluation of multiple treatment regimens and rapid integration of new evidence. The project brings together a consortium of African and European institutions to build capacity, foster collaboration, and generate high-quality evidence to inform clinical practice and policy.
The project’s specific objectives include:
• Establishing a robust governance and operational framework for a fit-for-purpose trial platform.
• Conducting innovative clinical trials incorporating adaptative and platform elements to address antibiotic treatment of neonatal sepsis.
• Performing pharmacokinetic studies to optimise dosing of key antimicrobials to be taken forward in trials.
• Implementing real-time surveillance of neonatal sepsis and AMR trends to improve understanding of research gaps.
• Building capacity through training and stakeholder engagement, including families, clinicians, and regulators.
SNIP-AFRICA is expected to significantly improve neonatal outcomes, strengthen research capacity in sSA, and contribute to global efforts to combat AMR.
During the first period (July 2023–December 2024), SNIP-AFRICA made substantial progress across all work packages:
• Surveillance (WP2): A surveillance protocol was developed and approved, with data collection tools and dashboards designed to monitor clinical and microbiological trends across seven neonatal units in five sSA countries.
• Adaptive Platform Design (WP3): A master protocol and governance charter were drafted, laying the foundation for a scalable and adaptable trial platform. The platform has already expanded to include a long-term follow-up study.
• Pharmacokinetics (WP4): A generic PK protocol and electronic case report forms were developed. The first PK study (PRECISION) has begun enrolling participants, with assay validation completed.
• Clinical Trials (WP5): The NeoSep1 Part 2 trial was launched, comparing multiple antibiotic regimens using adaptive designs. Country-specific appendices and trial databases were finalised, and regulatory approvals are underway.
• Training and Capacity Building (WP6): An online training platform was launched, and the first modules were made available. Collaborations with regional networks have been initiated to expand training opportunities.
• Stakeholder Engagement (WP7): Workshops with regulators, ethics committees, and parent representatives were conducted. A qualitative study on consent preferences (Neo-EPIC) was launched, and engagement with clinical staff has begun.
• Surveillance (WP2): A surveillance protocol was developed and approved, with data collection tools and dashboards designed to monitor clinical and microbiological trends across seven neonatal units in five sSA countries.
• Adaptive Platform Design (WP3): A master protocol and governance charter were drafted, laying the foundation for a scalable and adaptable trial platform. The platform has already expanded to include a long-term follow-up study.
• Pharmacokinetics (WP4): A generic PK protocol and electronic case report forms were developed. The first PK study (PRECISION) has begun enrolling participants, with assay validation completed.
• Clinical Trials (WP5): The NeoSep1 Part 2 trial was launched, comparing multiple antibiotic regimens using adaptive designs. Country-specific appendices and trial databases were finalised, and regulatory approvals are underway.
• Training and Capacity Building (WP6): An online training platform was launched, and the first modules were made available. Collaborations with regional networks have been initiated to expand training opportunities.
• Stakeholder Engagement (WP7): Workshops with regulators, ethics committees, and parent representatives were conducted. A qualitative study on consent preferences (Neo-EPIC) was launched, and engagement with clinical staff has begun.
SNIP-AFRICA is pioneering the use of adaptive platform trials for neonatal sepsis in sSA—a novel approach in this context. Key innovations include:
• Adaptive Trial Design: The integration of PRACTical and SMART methodologies allows for flexible, efficient evaluation of multiple treatment regimens.
• Real-Time Surveillance: The development of a harmonised, web-enabled surveillance system provides timely data to inform clinical decisions and detect outbreaks.
• Pharmacokinetic Innovation: The creation of generic PK protocols and analysis plans tailored to neonates addresses a critical gap in dosing data for this vulnerable population.
• Capacity Building: The project is fostering a new generation of African researchers and trialists, with a focus on sustainability and local ownership.
To ensure further uptake, SNIP-AFRICA will require continued investment in infrastructure, regulatory alignment, and integration with national health systems. The project also highlights the need for supportive policies on data sharing, ethical oversight, and antimicrobial stewardship.
• Adaptive Trial Design: The integration of PRACTical and SMART methodologies allows for flexible, efficient evaluation of multiple treatment regimens.
• Real-Time Surveillance: The development of a harmonised, web-enabled surveillance system provides timely data to inform clinical decisions and detect outbreaks.
• Pharmacokinetic Innovation: The creation of generic PK protocols and analysis plans tailored to neonates addresses a critical gap in dosing data for this vulnerable population.
• Capacity Building: The project is fostering a new generation of African researchers and trialists, with a focus on sustainability and local ownership.
To ensure further uptake, SNIP-AFRICA will require continued investment in infrastructure, regulatory alignment, and integration with national health systems. The project also highlights the need for supportive policies on data sharing, ethical oversight, and antimicrobial stewardship.