Phase 2Recruiting
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB (PARADIGM4TB)
A Seamless Phase 2B/C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis
- Sponsor
- University College, London (Academic or other)
- Enrollment
- 2,500 planned
- Conditions
- Pulmonary Tuberculosis
- Interventions
- Ganfeborole; BTZ-043; Bedaquiline (B); Delamanid (D); Pretomanid (Pa); Moxifloxacin (M); Linezolid (L); Pyrazinamide (Z); Rifampicin (R); Isoniazid (H); Ethambutol (E); Delpazolid (DZD)
- Ages
- adults, older adults
- Registry
- NCT06114628
Full record on ClinicalTrials.gov
From the registry
The UNITE4TB consortium is a group of universities and pharmaceutical companies funded by the European Union. This consortium are carrying out a trial to find better and faster ways to treat tuberculosis (TB). The standard treatment for TB takes 24 weeks and uses four drugs. The consortium want to find new treatments that are faster but just as safe and effective. In the trial, two new drugs will be used, BTZ-043 and GSK3036656, along with the drugs that are already used to treat TB in a variety of combinations (11 different combinations initially). These new drugs have worked well in tests with animals and have reduced the amount of TB bacteria in people's sputum/phlegm when used alone for two weeks. These new drugs will be used in combination with other TB drugs for a longer time (up to 16 weeks) in people with TB. The UNITE4TB consortium want to see if they work well and are safe. This trial will take place at sites across the world and will involve people with TB of the lungs that would usually respond well to the standard treatment. But the new treatments being tested might…
Primary outcomes
- Rate of change in log10(Time to Positivity of MGIT culture) (Phase 2B)
- Favourable/Unfavourable outcome (Phase 2C)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered