Current treatments for TB use a “one-size-fits-all” approach for patients that is long, complicated to track and can have severe side-effects. Patients must undergo combination therapy for at least six months and failure to comply can lead to the development of multi-drug resistant TB. Treating this type of TB can take up to two years of additional, expensive therapy and only 50 percent of patients survive. Shortening the standard treatment of TB is therefore a public health priority that can help reduce drug resistance and disease burden in developing countries.
Therefore, 7 major funders from China, Europe and the USA have joined forces to support the PredictTB consortium:
PredictTB (full title: “Using Biomarkers to Predict TB Treatment Duration”) is supported by The Foundation for the National Institutes of Health (FNIH) through a $13 million donation from the Bill & Melinda Gates Foundation, $8.4 million from the European & Developing Countries Clinical Trials Partnership (EDCTP), as well as additional contributions by the National Institutes of Health, Grand Challenges China, as well as the NIH’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 in the Republic of South Africa (RePORT South Africa).Read more
The project will implement a prospective, randomized, noninferiority phase 2b clinical trial, enrolling and following-up 620 patients with drug sensitive pulmonary TB in five collaborating sites in Cape Town, South Africa and four sites in Henan Province, China. Over the next 66 months, the project team will evaluate a set of criteria to reduce TB treatment times using data from scans, assays and cultures to evaluate inflammation and lung pathology, to test for the sustained presence of bacteria and to determine which patients are eligible for shortened treatment.
Key objectives of PredictTB:
- Enroll and follow-up 620 patients with drug sensitive pulmonary TB in a clinical trial to validate candidate biomarkers as well as identify and evaluate new, improved criteria that can identify patients who can be cured with shorter treatment
- Store biological samples (including serum, whole blood RNA, sputum, saliva, and urine) from patients in Africa and Asia for future biomarker research
- Develop a point-of-care lateral flow device that helps to decide which patients are eligible for shortened treatment