The Project

PredictTB was a 66-month project financed by a variety of international funders and implemented by American, African, Asian and European partners, that aimed 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 performed an ambitious phase 2B clinical trial in South Africa and China seeking to 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 were eligible for shorter TB treatment than the current standard of care.

PredictTB Objectives

1

Trial implementation

Initially aiming to enroll and follow up 620 patients with drug-sensitive pulmonary TB in a clinical trial, in the end, the PredictTB study enrolled 686 patients to validate candidate biomarkers as well as identify and evaluate new, improved criteria that could identify patients who could be cured with shorter treatment.

2

Sample collection & storage

The consortium has collected and stored biological samples (including serum, whole blood RNA, sputum, saliva, and urine) from patients in Africa and Asia for future biomarker research.

3

Test development

Project partners in the Netherlands focused on the development of a point-of-care lateral flow device that helps doctors decide which patients are eligible for shortened treatment. A 3/5 marker set and test device as an additional TB stopping criteria is evolving; however, it requires validation in a larger cohort.