Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding (RADIO-TB Trial)
Pakistan, South Africa, Zimbabwe784 participantsStarted 2025-11
Plain-language summary
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 treatment?
3. Are there better tests to confirm TB than the current routinely used, sputum-based tests?
4. What is the cost effectiveness of different treatment strategies and what might the impact on transmission be within communities?
Participants in the trial will be randomized into six groups: five receiving immediate standard TB treatment of varying durations (8 to 24 weeks), and one receiving deferred treatment with close monitoring. Deferred treatment will be initiated only if clinical deterioration occurs or TB is later confirmed. Participants will be closely followed for 78 weeks with at least 11 clinic visits.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Aged ≥16 years old on day of randomisation
✓. ≥25kg in weight on day of randomisation
✓. Participation in community or facility-based active case finding for TB by CXR
✓. Digital CXR with Computer Aided Detection software score above threshold for sputum investigation for Mtb according to local guidance ≤21 days prior to randomisation
✓. Attempted sputum collection for testing by WHO approved rapid molecular test for Mtb at active case finding and at screening
Exclusion criteria
✕. Sputum sample from active case finding or screening confirmed as positive for Mtb by WHO approved rapid molecular test for Mtb
✕. Previous history of pulmonary TB
✕. TB preventive therapy taken within the last 6 months
✕. \>1 dose of treatment with anti-tuberculous activity taken in the 21 days prior to randomisation
What they're measuring
1
Proportion of participants with an unfavourable TB outcome
. HIV infected, unless CD4 ≥200 cells/mm3 and on anti-retroviral therapy for at least 8 weeks
✕. Pregnancy (confirmed by high sensitivity urine test)
✕. Contraindication to study drug
✕. 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