Status:
NOT_YET_RECRUITING
Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding (RADIO-TB Trial)
Lead Sponsor:
University College, London
Collaborating Sponsors:
National University of Medical Sciences, Pakistan
Aurum Institute
Conditions:
Tuberculosis (TB)
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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 u...
Detailed Description
Increasingly, countries are adopting community-based chest X-ray (CXR) screening strategies to identify people with TB at an early stage, often before they have symptoms. However, a significant propor...
Eligibility Criteria
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
- 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
- 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
- CXR changes considered more likely to relate to a condition other than untreated TB by investigator
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
784 Patients enrolled
Trial Details
Trial ID
NCT07163143
Start Date
November 1 2025
End Date
April 1 2029
Last Update
September 9 2025
Active Locations (4)
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1
National University of Medical Sciences
Islamabad, Pakistan
2
Clinical HIV Research Unit, Wits Health Consortium
Johannesburg, South Africa
3
The Aurum Institute
Johannesburg, South Africa
4
Bulawayo City Health
Bulawayo, Zimbabwe