Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
ConditionPulmonary Tuberculosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 years or above at screening (or above age of legal consent at screening, if this is higher than 18 years in the jurisdiction in which the study is taking place)
Symptoms consistent with pulmonary TB at screening AND/OR
Imaging findings consistent with active pulmonary TB on chest X-ray performed at screening or within 7 days prior to screening
a semi-quantitative result of 'medium' or 'high' AND
Disqualifiers
Taken more than 1 daily dose of medication with anti-tuberculous activity during the 14 days prior to randomisation (isoniazid, rifampicin, pyrazinamide, ethambutol; linezolid, moxifloxacin, levofloxacin or amikacin) (for Phase 2b and Phase 2c)
Known isoniazid resistance (at sites where national isoniazid monoresistance is greater than 10% rapid testing at screening is mandated; at other sites rapid testing at screening is optional)
Known or suspected extra-thoracic TB, miliary TB or disseminated TB (in the judgement of the investigator; note uncomplicated pleural effusion occupying <50% of hemithorax or concomitant intra- or extra-thoracic lymphadenopathy are not exclusions)
Severe clinical pulmonary TB e.g. respiratory failure or complications likely to require hospital admission in the opinion of the investigator
Trial design
Treatments tested in this trial
- Ganfeborole
- BTZ-043
- Bedaquiline (B)
- Delamanid (D)
- Pretomanid (Pa)
- Moxifloxacin (M)
- Linezolid (L)
- Pyrazinamide (Z)
- Rifampicin (R)
- Isoniazid (H)
- Ethambutol (E)
- Delpazolid (DZD)
- Quabodepistat (Q)
Treatment groups
2,500 Participants
are divided into 17 treatment groups17
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University College, London
Lead sponsor
Radboud University Medical Center
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
University of Oxford
Collaborator
Research Center Borstel
Collaborator
Lygature
Collaborator
TASK Applied Science
Collaborator
Università Vita-Salute San Raffaele
Collaborator
Helmholtz Zentrum Munchen
Collaborator
KNCV Tuberculosis Foundation
Collaborator
Critical Path Institute
Collaborator
European Lung Foundation
Collaborator
Instituto de Saude Publica da Universidade do Porto
Collaborator
University of Liverpool
Collaborator
Institut de Recherche pour le Developpement
Collaborator
University of Hamburg-Eppendorf
Collaborator
University of California, San Francisco
Collaborator
TB Alliance
Collaborator
Find
Collaborator
University of Milano
Collaborator
University of St Andrews
Collaborator
Uppsala University
Collaborator
European Respiratory Society
Collaborator
Tuberculosis Network European Trialsgroup
Collaborator
Janssen, LP
Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator
German Center for Infection Research
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
University of Cambridge
Collaborator
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov