Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
Status:
Recruiting
Trial end date:
2027-08-11
Target enrollment:
Participant gender:
Summary
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 also work for people with drug resistant TB, that's harder to treat.
The trial has two parts. In the first part, different combinations of drugs will be tried on
up to 700 people for 16 weeks. These combinations will be compared to the standard 24-week
treatment to see which ones work the best and are safe.
In the second part, the best combinations from the first part will be taken to try to find
out what the best length of time is to give the treatment for. These combinations will be
tried on up to 1800 people giving them either 8, 10, 12, 14 or 16 weeks treatment. The
investigators will follow these people for a total of 72 weeks to make sure the treatment is
working.
The UNITE4TB consortium hope that this trial will find new treatments that are fast, safe,
and effective for both regular TB and resistant TB. If it works, it can then be tested again
in a bigger trial to be sure.
Phase:
Phase 2
Details
Lead Sponsor:
University College, London
Collaborators:
Critical Path Institute European Lung Foundation European Respiratory Society Find German Center for Infection Research GlaxoSmithKline Helmholtz Zentrum Munchen Institut de Recherche Pour le Developpment Instituto de Saude Publica da Universidade do Porto Janssen, LP KNCV Tuberculosis Foundation LMU University Hospital Munich London School of Hygiene and Tropical Medicine Lygature Otsuka Pharmaceutical Development & Commercialization, Inc. Radboud University Medical Center Research Center Borstel TASK Applied Science TB Alliance Tuberculosis Network European Trialsgroup University of California, San Francisco University of Cambridge University of Hamburg-Eppendorf University of Liverpool University of Milano University of Oxford University of St Andrews Uppsala University Vita-Salute San Raffaele University