Appraising the Critical Role of prognostic Biomarkers in the Assessment and Triage of sick African newborns: Advancing a point-of-care device based on sTREM-1 towards CE marking and implementation

Projektinformationen

ACROBAT Newborns

ID Finanzhilfevereinbarung: 101158797

DOI

10.3030/101158797

EK-Unterschriftsdatum 28 Oktober 2024

Startdatum 1 Januar 2025

Enddatum 31 Dezember 2029

Finanziert unter

• Health

Gesamtkosten

€ 4 808 065,00

EU-Beitrag

€ 4 808 065,00

Koordiniert durch

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA
Spain

Periodic Reporting for period 1 - ACROBAT Newborns (Appraising the Critical Role of prognostic Biomarkers in the Assessment and Triage of sick African newborns: Advancing a point-of-care device based on sTREM-1 towards CE marking and implementation)

Berichtszeitraum: 2025-01-01 bis 2025-12-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

Newborns are at the greatest risk of dying from severe infections, such as sepsis. According to the World Health Organization (WHO), there are between 1.3 and 2.9 million cases of these infections each year, resulting in 400,000 to 700,000 annual deaths worldwide. This burden is disproportionately higher in low- and middle-income countries, particularly in Africa. Around 84% of neonatal deaths from infection could be prevented with early detection. However, this is challenging in newborns due to the nonspecific nature of symptoms, the rapid progression of the disease, and that current methods for assessing infection severity often fall short, leading to misclassification and delayed care.

ACROBAT-newborns (Appraising the Critical Role of prognostic Biomarkers in the Assessment and Triage of sick African newborns) is a consortium led by the Barcelona Institute for Global Health (ISGlobal) and funded by the European Union’s EDCTP3 program, aimed at evaluating the performance of xTREM, a rapid point-of-care prognostic test that measures the levels of the biomarker sTREM-1 at the bedside, to predict severe illness (regardless of its cause) in sick newborns at their first encounter. The project will be conducted in four hospitals in Africa: Ethiopia, Gabon, Mozambique, and Uganda. This new risk-stratification tool could be a paradigm change that transforms neonatal triage, helping to predict severe illness, prevent mortality, and reduce long-term sequelae.


ACROBAT-newborns is a consortium coordinated by ISGlobal, consisting of 10 partners from Europe, the United Kingdom, and Africa. This 5-year project is structured around three main work pillars:

1) A clinical cohort study recruiting up to 4,000 sick and 400 healthy newborns across four hospitals in low-income countries, aiming not only to evaluate the performance of xTREM but also to advance the discovery of additional prognostic biomarkers;
2) An innovation and go-to-market strategy to accelerate the valorization of the device, the industrialization of its prototype, and its commercialization to ensure it reaches markets in resource-limited settings;
3) An evaluation of the overall impact of xTREM from the perspectives of health economics, health impact assessment, and socio-behavioral sciences, including usability, acceptability, and feasibility studies.

The project officially started in January 2025 and will run until December 2029. During this period, ACROBAT-newborns will focus on developing innovative solutions for neonatal care, providing high-quality evidence to support healthcare professionals’ decision-making, improve outcomes and survival, and optimize the use of healthcare resources.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

During its first year of implementation (January–December 2025), ACROBAT‑newborns made solid progress in establishing the scientific, regulatory, and operational foundations necessary for the project’s successful execution and start of the clinical study. Coordinated by ISGlobal, the consortium advanced across the key pillars (clinical study preparation and innovation development) while building a strong governance and communication framework for efficient collaboration among partners. Work on project coordination (WPs 1 and 2) focused on establishing governance structures, including the General Assembly, Project Steering Committee, and Ethics Advisory Board, which guide strategic and scientific decisions. Key management tools such as the Project Management Handbook, Dissemination and Communication Plan, and legal documents and agreements for data and material transfers were finalized, alongside the launch of the project website and external communications through institutional and social media channels.
The clinical study (WP3) achieved an important milestone with the completion of the international clinical protocol, informed consent forms, and electronic CRFs. Sites where recruitment will take place (Mozambique, Uganda, Gabon, and Ethiopia) are now proceeding with local scientific and ethical submissions.
Regarding the laboratory component of the consortium (WP4), the basis for strengthening laboratory capacity and preparation have started to ensure adequate biomarker discovery and validation. The data infrastructure and statistical planning (WP5) was established according to the project’s objectives and the multisite clinical study protocol, with the development of the Data Management Plan and the Statistical Analysis Plan (D5.2). Parallel to these activities, preparatory work advanced for health economics, health impact assessment, and the sociobehavioral component regarding usability, acceptability, and feasibility (WPs 6 and 7), including literature reviews, the writing of the ancillaries protocol, and defining the information to be collected in accordance with the clinical protocol.
The innovation and market strategy pillar (WP8 and WP9) has initiated the setup of the Quality Management System for device industrialization, introducing the xTREM device into selected African markets, and CE‑marking. This included the identification of Spotlab S.L. as the subcontracting entity for the development of the Clinical Risk Assessment App that will integrate the interpretation and use of test results into a mobile application. In addition, ethical compliance activities (WP10) progressed in parallel to the previous reported activities. Overall, during the first reporting period, the ACROBAT-newborns consortium has successfully transitioned from the planning to the pre‑implementation stage, ensuring that operational, regulatory, and ethical conditions are in place for the start of clinical study and device evaluation.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

ACROBAT‑newborns is advancing beyond the current state of the art by pioneering a biomarker-based innovative prognostic point‑of‑care device (xTREM) capable of predicting severe outcomes in sick newborns regardless of underlying cause, which is an unmet need in neonatal care globally. The integration of sTREM‑1 quantification with a robust clinical study, advanced analytics, multiplex biomarker discovery, and the health economics, health impact assessment, and acceptability, usability and feasibility studies, represents a novel approach to neonatal triage, particularly in African settings where higher difficulties are found for triaging newborns, and subsequent healthcare access and provision. The forthcoming steps include analytical and clinical validation of the xTREM device, and follow the steps for obtaining CE‑mark certification and the defined business plan. We are working in ensuring necessary strategies and efforts on partnerships for manufacturing and industrialization, and regulatory alignment in Africa that will be essential to ensure sustainable and accessible access globally.