DRTB-HDT - Stratified Host-Directed Therapy for Rifampicin-Resistant TB: A Randomized Controlled Multi-Centre Trial
Tuberculosis (TB) has historically been the most common infectious cause of death globally, surpassed only recently (and presumably temporarily) by the ongoing Covid-19 pandemic. TB treatment is lengthy and often unsuccessful. Even if cured, most patients are left with impaired lung function and shortened longevity. Rifampin-resistant tuberculosis (RIF-R-TB) patients do not respond to the standard TB treatment with rifampin and are therefore at increased risk of death, treatment failure, and impaired post-TB lung function. This project investigates two complementary therapies alongside the standard RIF-R-TB treatment in a randomized, controlled phase 2 clinical trial in five countries (Moldova, Romania, Georgia, Mozambique and South Africa). Patients will receive either CC-11050 (a drug that reduces inflammation) or metformin (a drug that changes cellular metabolism) and be compared to patients receiving the standard RIF-R-TB treatment alone. The study will examine patients’ lung function (how much air can be forced out of the lungs in one deep sigh) and sputum culture conversion, meaning whether tuberculosis bacilli are coughed up and can still be detected in sputum after treatment. Thus the main objective of this project is to determine the efficacy, safety and tolerability of two adjunctive host-directed therapies in RIF-R-TB patients and identify baseline risk factors for poor treatment outcome. To achieve the second objective, the trial is accompanied by an analysis of the social and economic impact of treatment on TB patients.
This project is coordinated by Swiss TPH, the sponsor of the trial is the Aurum Institute, South Africa