Successful kickoff meeting launches international Stool4TB project

Earlier this week, Stool4TB, a large international project which aims to evaluate a new stool-based test for diagnosis of tuberculosis in children and people living with HIV, held its 3-day kick-off virtual meeting. This 4-year project is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) and is coordinated by ISGlobal in collaboration with five research institutions. In addition to contributing to the scientific process, AIGHD will be involved in the communication, dissemination, and exploitation of this project. Dr. Sabine Hermans will act as project lead for Stool4TB, which has also had generous input from Prof. Frank Cobelens. The project consortium members include the Research Center Borstel in Germany, Centro de Investigação em Saude de Manhiça (CISM), in Mozambique, Makerere University in Uganda, and Baylor Foundation Eswatini in Eswatini. In addition, Baylor College of Medicine in Houston, United States, will be a collaborating institution of Stool4TB.

Tuberculosis (TB) continues to be a leading cause of morbidity and mortality among children and people living with HIV (PLHIV). Despite significant progress in TB diagnostics, TB laboratory confirmation is particularly challenging in children and PLHIV. In consequence, bacteriological confirmation of pulmonary TB in young children and immunosuppressed PLHIV remains disappointingly low. Inability to bacteriologically confirm TB results in both i) under-diagnosis which leads to worse outcomes including increased mortality and ii) over (mis)diagnosis, and poor resource allocation. Given the limitations of currently available sputum-based diagnostic tests in these vulnerable populations, there is a need to develop new tools and identify easy to collect non-respiratory specimens which, combined, could improve bacteriological confirmation.

Stool4TB will validate an innovative stool homogenization and DNA isolation method that yields a highly sensitive and specific Mycobacterium tuberculosis 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 HIV positive adults, while proving feasible and acceptable. Preliminary data suggest that this platform adds value to existing sputum-based diagnostics and increases rates of bacteriological confirmation. This platform has the potential to be adapted to a point-of-care diagnostic and thus easily implemented in resource-constrained basic health care centres. In addition, the project will assess the feasibility, usability and acceptability of stool collection from both the patient and the health system perspective.

STool4TB represents a unique opportunity to create a TB diagnostic network among European and African high TB burden countries with the capacity to conduct clinical studies of novel diagnostics with a focus on children and people living with HIV.