Tests how long TB treatment must last in people with unconfirmed TB
Tests how long TB medicines are needed, or delayed treatment, in people with unconfirmed TB.
Plain-language title generated from the registry record
Registry title: Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding (RADIO-TB Trial)
Key facts
- Where
- Bulawayo, ZimbabweSee the site
- Phase
- Phase 3
Where in Zimbabwe
- Bulawayo City HealthBulawayo, ZimbabweTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University College, London
- Trial code
- NCT07163143
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding
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.
Inclusion: 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: 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; Contraindication to study drug; HIV infected, unless CD4 ≥200 cells/mm3 and on anti-retroviral therapy for at least 8 weeks; CXR changes considered more likely to relate to a condition other than untreated TB by investigator; Sputum sample from active case finding or screening confirmed as positive for Mtb by WHO approved rapid molecular test for Mtb; Pregnancy (confirmed by high sensitivity urine test); 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; Investigator assessment of an immediate requirement for full 24-weeks standard TB treatment; Investigator assessment of unacceptable risks to potential participant from study entry; No fixed home address; Unable to participate in the full duration of study follow-up.