Actively Recruiting
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
Led by University College, London · Updated on 2025-10-06
2500
Participants Needed
11
Research Sites
187 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (or above legal consent age in the study location)
- Clinical signs of active pulmonary TB with symptoms and/or chest X-ray consistent with active TB
- At least one sputum test showing medium or high TB bacteria amount without rifampicin resistance
- Body weight between 30 and 100 kg and BMI between 15 and 40 kg/m2
- Willingness to attend all study visits and comply with study procedures
- Resident at a fixed address accessible for visits and likely to remain for the trial duration
- Provided written informed consent
You will not qualify if you...
- Use of anti-tuberculous medication for more than one daily dose in the 14 days before randomisation
- Known isoniazid resistance (testing required where prevalence is high)
- Known or suspected extra-thoracic, miliary, or disseminated TB (except certain pleural or lymph node cases)
- Severe pulmonary TB or respiratory failure likely needing hospital admission
- Poor general health or urgent need for treatment as judged by investigator
- Active cancer requiring systemic or palliative treatment
- History of significant heart disease, arrhythmias, long QT syndrome, or uncontrolled hypertension
- Vitiligo
- History of seizures
- Current tendinitis or fluoroquinolone-related tendinopathy
- History of vascular aneurysm
- Symptomatic peripheral neuropathy interfering with daily activities
- Current alcohol or drug use compromising safety or study adherence
- Use of amphetamines or methamphetamines recently or detected by screen
- Other significant medical or social conditions affecting safety or compliance
- Pregnant or breastfeeding women
- Women of childbearing potential not agreeing to effective contraception and reproductive restrictions
- Men unwilling to use condoms and reproductive restrictions during and after treatment
- Known allergy to any study drug
- Taking medications that interact with study drugs and cannot be stopped or safely managed
- Use of medications that prolong QTc interval that cannot be stopped safely
- Recent immunosuppressive treatments except short systemic corticosteroids or low-dose topical/inhaled steroids
- Participation in other clinical trials with investigational agents within 8 weeks
- ECG showing prolonged QTcF or other significant abnormalities
- Abnormal laboratory values including low blood counts, impaired kidney function, or elevated liver enzymes
- Positive tests for hepatitis B surface antigen, HIV antibody, or known hepatitis C infection without negative PCR test
AI-Screening
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Trial Site Locations
Total: 11 locations
1
PMSI Institute of Pneumology "Chiril Draganiuc"
Chisinau, Moldova
Active, Not Recruiting
2
TASK Brooklyn
Cape Town, South Africa
Actively Recruiting
3
University of Cape Town Lung Institute
Cape Town, South Africa
Actively Recruiting
4
TASK Eden
George, South Africa
Actively Recruiting
5
NIMR Mbeya
Mbeya, Tanzania
Actively Recruiting
6
Kibong'oto Infectious Diseases Hospital
Moshi, Tanzania
Actively Recruiting
7
NIMR Mwanza
Mwanza, Tanzania
Actively Recruiting
8
Joint Clinical Research Centre
Kampala, Uganda
Actively Recruiting
9
Makerere University Lung Institute
Kampala, Uganda
Actively Recruiting
10
National Lung Hospital
Hanoi, Vietnam
Active, Not Recruiting
11
Pnth/Oucru
Ho Chi Minh City, Vietnam
Active, Not Recruiting
Research Team
S
Susie Slater
CONTACT
K
Karen Sanders
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
17
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