The FNIH Launches New Project to Reduce Treatment Times for Drug-Sensitive Tuberculosis

June 15, 2017 – The Foundation for the National Institutes of Health (FNIH) has launched a new project to shorten the treatment times of tuberculosis (TB) in drug-sensitive patients through individualized therapy. The $24 million project, “Using Biomarkers to Predict TB Treatment Duration” (PredictTB), is funded in-part by the FNIH through a $13 million donation from the Bill & Melinda Gates Foundation, with management support provided by the National Institute of Allergy and Infectious Diseases (NIAID) and Catalysis Foundation for Health.

Treating TB is a long and complicated process that requires at least six months of combination therapy. Failure to comply with the process can cause multi-drug resistant (MDR) TB, which may take up to two years of additional, expensive therapy and only 52 percent of patients are successfully treated. Shortening TB treatment times is a public health priority that can help reduce drug resistance and disease burden in developing countries.

To identify the set of criteria needed to reduce TB treatment times, the PredictTB project team will enroll up to 620 patients with drug sensitive pulmonary TB in a clinical trial with five collaborating sites in Cape Town, South Africa and four in Henan Province, China. Over five years, the team will test criteria using data from radiographic lung scans, assays of patient body fluids and analysis of bacterial cultures. They will evaluate the initial burden of disease, the rate of response to therapy and the presence of TB-causing bacteria in drug adherent patients. Assessment of these risk factors will be used to identify patients who are successfully treated and those that need additional therapy. Patients will then be followed for a year after completing treatment to assess relapse rates.

Additional support for PredictTB comes from the European & Developing Countries Clinical Trials Partnership (EDCTP) executed through Stellenbosch University and LINQ Management, Grand Challenges China, the National Institutes of Health’s International Collaborations in Infectious Disease Research (ICIDR) Program in collaboration with the Consortium for TB Biomarkers and the Regional Prospective Observational Research in Tuberculosis (RePORT South Africa Consortium).

The initial results from PredictTB are expected in January 2023. To learn more and stay up-to-date on the project, visit fnih.org/PredictTB.

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