New prospective study for the diagnosis of paediatric and extra-pulmonary TB starts in Bangladesh
Meeting at the International Centre for Diarrhoeal Disease Research in Bangladesh (icddr,b), teams at the Mérieux Foundation and icddr,b are officially launching a new clinical research project to measure the performance of two innovative blood tests for the triage and diagnosis of paucibacillary forms of tuberculosis (paediatric and extra-pulmonary).
The DEDICATE (blooD-basEd DIagnostiC of pAucibacillary Tb in bangladEsh) study, made possible by an exceptional donation from bioMérieux dividends, is being conducted jointly by the Mérieux Foundation and the icddr,b teams, with the support of Cepheid® and under the responsibility of Dr Sayera Banu, head of the Emerging Diseases Program of the icddr,b Infectious Diseases Department.
A triage test for TB using a sample that is not sputum based is one of the WHO’s main priorities. To date, molecular blood tests including RISK6 or the Cepheid® Xpert-MTB-HR prototype, both based on the detection of a transcriptomic signature in the host, represent a promising and innovative alternative for the diagnosis of paucibacillary forms of tuberculosis.
In 2021, the HINTT research consortium, coordinated by the Mérieux Foundation as part of the GABRIEL network, demonstrated that the RISK6 blood test had excellent performance in terms of sensitivity and specificity for screening and monitoring the treatment of pulmonary tuberculosis in adults.
Based on these results, the Mérieux Foundation and its partners have just launched the DEDICATE project in Bangladesh, which aims to evaluate the performance of the two blood tests RISK6 and Xpert-MTB-HR for the triage and diagnosis of paediatric and extra-pulmonary tuberculosis.
This 18-month prospective study is an observational study in a hospital environment following two cohorts. The first cohort is composed of children under 15 years of age with suspected pulmonary tuberculosis and the second is made up of children, adolescents and adults suspected of having extra-pulmonary tuberculosis and referred to the icddr,b TB screening and treatment centre.
The second phase of the project proposes to evaluate these same blood tests as tools for monitoring the effectiveness of TB treatment and their ability to distinguish between microbiological and clinical forms of paucibacillary TB.
This study is part of the WHO’s plan to combat tuberculosis worldwide, and more specifically the theme of reducing the morbidity and mortality of this disease in countries with limited resources and the highest rates of TB.