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Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding (RADIO-TB Trial)

RecruitingPhase 3Ages 16 Years - anyAllUniversity College, London
NCT07163143 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

People living in high TB burden communities who undergo active case finding for TB may have chest X-ray changes suggestive of TB but their sputum test can be negative for the TB bacteria or they are unable to provide a sputum sample. This means they have bacteriologically unconfirmed TB. These individuals often have minimal or no symptoms and face uncertainty in clinical management-either receiving full 24-weeks TB treatment or often being discharged without treatment, risking loss to follow-up. The RADIO-TB trial aims to address the following main questions in relation to people with bacteriologically unconfirmed TB. 1. What is the risk of progression if treatment is not immediately started but there is close and careful follow-up over 78 weeks? 2. If treatment is started immediately what is the shortest duration of TB treatment that is as effective as the standard 24-week TB treatmen

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged ≥16 years old on day of randomisation 2. ≥25kg in weight on day of randomisation 3. Participation in community or facility-based active case finding for TB by CXR 4. Digital CXR with Computer Aided Detection software score above threshold for sputum investigation for Mtb according to local guidance ≤21 days prior to randomisation 5. Attempted sputum collection for testing by WHO approved rapid molecular test for Mtb at active case finding and at screening Exclusion Criteria: 1. Sputum sample from active case finding or screening confirmed as positive for Mtb by WHO approved rapid molecular test for Mtb 2. Previous history of pulmonary TB 3. TB preventive therapy taken within the last 6 months 4. \>1 dose of treatment with anti-tuberculous activity taken in the 21 days prior to randomisation 5. HIV infected, unless CD4 ≥200 cells/mm3 and on anti-retroviral therapy for at least 8 weeks 6. Pregnancy (confirmed by high sensitivity urine test) 7. Contraindication to study drug 8. Investigator concern for potential extra-pulmonary TB with the exceptions of (a) intrathoracic lymphadenopathy; and/or (b) small pleural effusion of limited extent, neither felt to require invasive diagnostic sampling 9. CXR changes considered more likely to relate to a condition other than untreated TB by investigator 10. Investigator assessment of an immediate requirement for full 24-weeks standard TB treatment 11. Investigator assessment of unacceptable risks to potential participant from study entry 12. No fixed home address 13. Unable to participate in the full duration of study follow-up
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What it tests

  • Isoniazid (H)
  • Rifampicin (R)
  • Pyrazinamide (Z)
  • Ethambutol (E)
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Where

4 sites
National University of Medical Sciences
Islamabad, Pakistan
Clinical HIV Research Unit, Wits Health Consortium
Johannesburg, South Africa
The Aurum Institute
Johannesburg, South Africa
Bulawayo City Health
Bulawayo, Zimbabwe
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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