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

Study acronym: PARADIGM4TB
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries Show 6 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 5 of 21 entries
    • Study description expanded, about 45 words
    • Site details revised at 3 of 11 sites
    • Collaborators revised (29)
    • Publications: details revised at 3 of 3 entries
  2. Study sites: 8 to 11
    • Interventions: BTZ-043 (Drug), Bedaquiline (B) (Drug), Delamanid (D) (Drug), Ethambutol (E) (Drug), GSK3036656 (Drug), Isoniazid (H) (Drug), Linezolid (L)… to BTZ-043 (Drug), Bedaquiline (B) (Drug), Delamanid (D) (Drug), Delpazolid (DZD) (Drug), Ethambutol (E) (Drug), Ganfeborole (Drug), Isoniazid…
    • Study arms: 12 to 17
    v5
  3. Study sites: 1 to 8v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 8, 2023 to Jan 9, 2024
    v3
  5. Start date: Nov 6, 2023 to Dec 8, 2023v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06114628
Lead Sponsor University College, London
Collaborators: Radboud University Medical Center, London School of Hygiene and Tropical Medicine, University of Oxford, Research Center Borstel, Lygature, TASK Applied Science, Università Vita-Salute San Raffaele, Helmholtz Zentrum Munchen, KNCV Tuberculosis Foundation, Critical Path Institute, European Lung Foundation, Instituto de Saude Publica da Universidade do Porto, University of Liverpool, Institut de Recherche pour le Developpement, University of Hamburg-Eppendorf, University of California, San Francisco, TB Alliance, Find, University of Milan, University of St Andrews, Uppsala University, European Respiratory Society, Tuberculosis Network European Trialsgroup, Janssen, LP, Otsuka Pharmaceutical Development & Commercialization, Inc., German Center for Infection Research, LMU Klinikum, University of Cambridge, GlaxoSmithKline
Conditions
(from sponsor)		 Pulmonary Tuberculosis
Related terms Tuberculosis, Pulmonary
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov