Pharmacokinetics and Efficacy of the Benzothiazinone BTZ-043 against Tuberculous Mycobacteria inside Granulomas in the Guinea Pig Model.
Emmelie Eckhardt, Yan Li, Svenja Mamerow...
https://pubmed.ncbi.nlm.nih.gov/36975792Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06114628
A Seamless Phase 2B/C Platform Trial to Evaluate Multiple Regimens and Treatment Durations in Pulmonary Tuberculosis
Led by University College, London · Updated on 2025-10-06
2500
Participants Needed
11
Research Sites
24 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
Researchers are investigating new treatment combinations for pulmonary tuberculosis (TB) to find faster and safe alternatives to the standard 24-week regimen. The study involves adults with newly diagnosed, rifampicin-susceptible lung TB, aiming to identify drug regimens with similar or better effectiveness and safety but shorter treatment times. This research is conducted by the UNITE4TB consortium, a team of universities and pharmaceutical companies funded by the European Union. The study has two phases: Phase 2B tests up to 12 different drug combinations, including new drugs like BTZ-043, GSK306656, bedaquiline, and delamanid, for 16 weeks to assess safety and effectiveness. Phase 2C will then evaluate the best regimens from Phase 2B at various treatment lengths ranging from 8 to 16 weeks, compared to the standard 24-week treatment. Participants receive daily oral doses of various drugs in different combinations, with treatment durations and regimens randomly assigned. Participants will be followed for a total of 72 weeks to monitor treatment response and safety. Researchers will assess sputum cultures for TB bacteria and record adverse events up to 26 weeks after starting treatment. The study includes regular visits, imaging, laboratory tests, and adherence monitoring to evaluate how well the treatments work and their side effects. The goal is to find effective shorter treatments for both regular and drug-resistant TB.
CONDITIONS
Brief Title
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (or above legal consent age in the study location)
- Clinical evidence of active pulmonary tuberculosis with consistent symptoms and/or chest X-ray findings
- At least one sputum sample with medium or high TB bacteria level and no rifampicin resistance
- Body weight between 30 and 100 kg and body mass index between 15 and 40 kg/m2
- Willingness to comply with study visits, procedures, and treatment observation
- Resident at a fixed address accessible for visits and likely to remain for trial duration
- Provided written informed consent
You will not qualify if you...
- Taken more than 1 daily dose of anti-tuberculous medication in the 14 days before randomization
- Known isoniazid resistance (with rapid testing required at some sites)
- Known or suspected extra-thoracic, miliary, or disseminated tuberculosis (except limited pleural effusion or lymphadenopathy)
- Severe pulmonary TB requiring hospital admission
- Poor general condition or inability to delay treatment safely
- Active cancer requiring systemic or palliative therapy
- History of heart disease, arrhythmias, pulmonary hypertension, or significant cardiac problems
- Vitiligo or history of seizures
- Current tendinitis or fluoroquinolone-associated tendinopathy
- History of vascular aneurysm
- Symptomatic peripheral neuropathy interfering with daily activities
- Current alcohol or illicit drug use compromising safety or adherence
- Recent use of amphetamines or methamphetamines
- Other significant medical or social conditions affecting safety or compliance
- Pregnant or breastfeeding women
- Women of childbearing potential unwilling to use effective contraception during and after treatment
- Men unwilling to use condoms during and after treatment and unwilling to refrain from semen donation
- Known allergy to study drugs
- Use of medications interacting with study drugs that cannot be safely stopped or replaced
- Prolonged QTc interval or clinically significant ECG abnormalities
- Abnormal laboratory values including low blood counts, impaired kidney function, or abnormal liver tests
- Positive hepatitis B surface antigen or hepatitis C infection without negative PCR test
- Positive HIV antibody test
- Recent treatment with immunosuppressive drugs
- Participation in another investigational drug trial within 8 weeks
- QTcF >450ms (men) or >460ms (women) or other significant ECG abnormalities at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 weeks depending on assigned regimen and phase
Participants are randomized to receive either the standard 24-week tuberculosis treatment regimen or one of several novel drug regimens for 16 weeks in Phase 2B. Those progressing to Phase 2C will be randomized to different treatment durations between 8 and 16 weeks or the 24-week standard regimen to evaluate optimal treatment duration.
Regular visits throughout treatment period
Follow-up
Duration - Up to 48 weeks after treatment completion, total participation up to 72 weeks
Participants are monitored for treatment outcomes and safety, including assessment of efficacy and adverse events up to 72 weeks from randomization.
Visits at weeks 48 and 72 for outcome assessments
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
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Research Team
S
Susie Slater
K
Karen Sanders
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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Published Research Related To This Trial
First-Time-in-Human Study and Prediction of Early Bactericidal Activity for GSK3036656, a Potent Leucyl-tRNA Synthetase Inhibitor for Tuberculosis Treatment.
David Tenero, Geo Derimanov, Alex Carlton...
https://pubmed.ncbi.nlm.nih.gov/31182528Discovery of a Potent and Specific M. tuberculosis Leucyl-tRNA Synthetase Inhibitor: (S)-3-(Aminomethyl)-4-chloro-7-(2-hydroxyethoxy)benzo[c][1,2]oxaborol-1(3H)-ol (GSK656).
Xianfeng Li, Vincent Hernandez, Fernando L Rock...
https://pubmed.ncbi.nlm.nih.gov/28953378