STool4TB is a project that aims to validate an innovative stool homogenization and DNA isolation method that yields a highly sensitive and specific Mtb qPCR-based diagnostic. STool4TB will evaluate this platform in the high TB and HIV burden settings of Mozambique, Eswatini and Uganda, under the hypothesis that it will narrow the large TB case detection gap by improving TB confirmation rates in children and PLHIV, while proving feasible and acceptable.

Preliminary data suggest that this platform adds value to existing sputum based diagnostics and increases rates of bacteriological confirmation. Given the lack of available tools to effectively monitor TB treatment, STool4TB will also evaluate the usefulness of this quantitative stool-based qPCR as a TB treatment monitoring tool for children and PLHIV.

This platform has the potential to be adapted to a POC diagnostic and thus easily implemented in resource-constrained basic health care centres. This proposal represents an opportunity to assess the feasibility, usability and acceptability of stool collection from both the patient and the health system perspective. STool4TB will create a biobank of comparative specimens provided by pediatric and HIV-positive TB patients (as well as TB-free individuals). The biobank will facilitate future evaluation of novel assays for pediatric TB diagnosis or drug resistance detection.

Finally, we aim to create a TB diagnostic network among African high TB burden countries with the capacity to conduct clinical studies of novel diagnostics and new drugs with a focus on children and PLHIV. This will be achieved by strengthening collaboration and sustaining capacity building activities among participating African institutions.

Total Funding

€ 2,999,989.25

The European & Developing Countries Clinical Trials Partnership (EDCTP) was established in 2003 and is a public-public partnership between countries in Europe and Sub-Saharan Africa, and the European Union. The programme aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in Sub-Saharan Africa, with a focus on phase II and III clinical trials.

EDCTP’s second programme (2014-2024) supports all clinical trial phases (I-IV) including health services optimisation research. Research and regulatory capacity development remain integrated in the research funding strategy in order to strengthen the conditions for conducting clinical research in Sub-Saharan Africa.

The EDCTP programme is executed through partnerships between European and African institutions and researchers in collaboration with the pharmaceutical industry and like-minded organisations.

The programme is implemented as part of the European Framework Programme for Research and Innovation, Horizon 2020, and governed by the participating African and European countries.