Optimal treatment duration for radiographically apparent TB without bacteriological confirmation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

RADIO-TB is a phase 3, multi-country, open-label, randomized trial in South Africa, Zimbabwe, and Pakistan. It compares six arms to determine the best 24-week TB treatment duration for radiographically suspected but bacteriologically unconfirmed TB identified through active case finding, aiming to balance effectiveness with potential over- or under-treatment. Participants are adults and older youths identified via community or facility screening, with radiographic TB signs and negative or non-diagnostic sputum tests. The study uses pragmatic methods and CAD-based chest X-ray scoring to guide inclusion and follows participants for up to roughly 78 weeks to assess outcomes. Lead sponsorship is from University College London, with regional collaborators and sites across the three countries.

Why it matters

Who can join: the full rules

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

Where it's running

• Bulawayo City Health
  Bulawayo, Zimbabwe Recruiting
• National University of Medical Sciences
  Islamabad, Pakistan Not yet recruiting
• Clinical HIV Research Unit, Wits Health Consortium
  Johannesburg, South Africa Not yet recruiting
• The Aurum Institute
  Johannesburg, South Africa Not yet recruiting

Study contacts

• Study coordinator: Hanif Esmail, Prof
• Email: h.esmail@ucl.ac.uk
• Phone: +44 20 7670 4700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.