PredictTB

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PredictTB is a five-year project financed by a variety of international funders and implemented by American, African, Asian and European partners, that aims to shorten the treatment times of tuberculosis (TB) in drug-sensitive patients through individualized therapy. Coordinated by Prof. Clifton Barry from the US National Institutes of Health and Prof. Gerhard Walzl from Stellenbosch University in South Africa, the consortium will perform an ambitious phase 2B clinical trial in South Africa and China and develop 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 treatment that is much shorter than the current standard of care.

Goals

  • 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.

Results & Accomplishments

Scientific Publications

Using biomarkers to predict TB treatment duration (PredictTB): a prospective, randomized, noninferiority, treatment shortening clinical trial. Chen, R.Y., Via, L.E., Dodd, L.E., Walzl, G., Malherbe, S.T., Loxton, A.G., Dawson, R., Wilkinson, R.J., Thienemann, F., Tameris, M., Hatherill, M., Diacon, A., Liu, X., Xing, J., Jin, X., Ma, Z., pan, S., Zhang, G., Gao, Q., Jiang, Q., Zhu, H., Liang, L. Gates Open Research 1:9, 6 November 2017, 10.12688/gatesopenres.12750.1

Media

EDTCP (March 20, 2017): PredictTB project launched: biomarkers to predict TB treatment duration.
Daily Dispatch (February 17, 2017): New study aims to shorten TB cure time.
Stellenbosch University (February 15, 2017): Ambitious new project ‘Predict-TB’ aims to cut treatment duration.
LINQ Management (February 10, 2017): From the current practice of "one size fits all" to precision-guided individualised TB therapy

Partners

Public-Sector Parnters:
National Institute of Allergy and Infectious Diseases (NIAID)

Private-Sector Partners:
Bill & Melinda Gates Foundation*
Catalysis Foundation for Health
European Research and Project Office GmbH
LINQ Management
TASK Foundation NPC

Academic Partners:
Fudan University
Stellenbosch University
University of Cape Town - Clinical Infectious Diseases Research Initiative
University of Cape Town - Institute of Infectious Disease and Molecular Medicine
University of Cape Town – South African Tuberculosis Vaccine Initiative
University of Cape Town Lung Institute (Pty) Ltd

*Provided financial or in-kind support for this program.

FNIH Contacts

Susan Wiener, Senior Project Manager; swiener@fnih.org

Tiffany Francis, C.P., Project Manager, PredictTB; tfrancis@fnih.org