PredictTB

Problem/ Solution

The Problem
Although standard-of-care therapies exist to treat tuberculosis (TB), patients with drug-sensitive strains of TB may be eligible for substantially shorter treatment times, if these patients/strains can be identified.
The Solution
The PredictTB project will confirm the ability of certain biomarkers to identify patients infected with drug-sensitive TB strains and assess whether these patients may be eligible for shorter treatments than the current standard of care.

Overview

PredictTB, a five-year project supported by a variety of international funders and implemented by American, African, Asian, and European partners, aims to use individualized therapy to shorten the time needed to treat tuberculosis (TB) in drug-sensitive patients. Coordinated by Prof. Clifton Barry from NIH and Prof. Gerhard Walzl from Stellenbosch University in South Africa, the PredictTB 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 with 620 patients with drug-sensitive pulmonary TB in a clinical trial to validate candidate biomarkers, as well as to identify and evaluate new and 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.

 

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 Read more

Partners

Public-Sector Partners

  • 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

Media 

  • EDCTP (March 20, 2017): PredictTB project launched: biomarkers to predict TB treatment duration. Read more
  • Daily Dispatch (February 17, 2017): New study aims to shorten TB cure time. Read more
  • Stellenbosch University (February 15, 2017): Ambitious new project ‘Predict-TB’ aims to cut treatment duration. Read more

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