ACT4KIDS-TB aims at closing the diagnostic gap for paediatric tuberculosis (TB) with a novel pioneering clinical decision-making (CDM)-app incorporating two transformative innovations (three-in-one): Actiphage and computer assisted diagnosis of CXRs (CAD) at the point-of-care (POC). ACT4KIDS-TB will be the first to determine the diagnostic yield of Actiphage, a repurposed bacteriophage-based PCR assay for blood in children. Actiphage detects viable mycobacteria within hours of sampling & with simplified laboratory requirements versus culture. ACT4KIDS-TB will also externally validate available paediatric CAD algorithms, including smartphone-based CXR images, which will evaluate performance at point-of-care via a new CAD-POC-app. The CDM-app will incorporate results from Actiphage, the CAD POC-app, patient characteristics & features of the setting to provide clinicians with a point-of-care, on-& offline, post-test TB probability to guide treatment decisions. ACT4KIDS-TB will recruit 206 children with presumptive TB as well as up to 150 health-care-workers and caregivers in South Africa & Benin, two high-TB burden settings. ACT4KIDS-TB includes robust cost-effectiveness, acceptability & feasibility studies for a clear technology transfer roadmap. ACT4KIDS-TB will add South-South capacity strengthening by providing two Sub-Saharan African PhDs & developing Open Access trainings for paediatric TB diagnosis. A diverse group of stakeholders facilitates intra-African collaborations; regional manufacturing & support translating research into policy & practice and technology scale-up. These stakeholders comprise industry (e.g. Delft Imaging), policy makers (WHO, Africa CDC, TEI-MAV+, …) as well as global scientific entities (WSPID, WARN-CARN-TB network…) ACT4KIDS-TB will transform paediatric TB with faster, low-resource, more accessible & cost-effective diagnostics using innovative technologies for a vulnerable population; young children in high-burden settings.
