A Phase 2B2C Global Trial Testing New Drug Combinations and Treatment Lengths for Pulmonary Tuberculosis

What this Trial Is About

Researchers are investigating new treatment combinations for pulmonary tuberculosis TB to find faster and safe alternatives to the standard 24-week regimen. The study involves adults with newly diagnosed, rifampicin-susceptible lung TB, aiming to identify drug regimens with similar or better effectiveness and safety but shorter treatment times. This research is conducted by the UNITE4TB consortium, a team of universities and pharmaceutical companies funded by the European Union. The study has two phases Phase 2B tests up to 12 different drug combinations, including new drugs like BTZ-043, GSK306656, bedaquiline, and delamanid, for 16 weeks to assess safety and effectiveness. Phase 2C will then evaluate the best regimens from Phase 2B at various treatment lengths ranging from 8 to 16 weeks, compared to the standard 24-week treatment. Participants receive daily oral doses of various drugs in different combinations, with treatment durations and regimens randomly assigned. Participants will be followed for a total of 72 weeks to monitor treatment response and safety. Researchers will assess sputum cultures for TB bacteria and record adverse events up to 26 weeks after starting treatment. The study includes regular visits, imaging, laboratory tests, and adherence monitoring to evaluate how well the treatments work and their side effects. The goal is to find effective shorter treatments for both regular and drug-resistant TB.

Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB