NCT06437184 Increased Tuberculosis Case Detection - DiOpTB
| NCT ID | NCT06437184 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,584 participants |
| Start Date | 2024-06-03 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,584 participants in total. It began in 2024-06-03 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
As estimated by the WHO 10.6 million new Tuberculosis (TB) cases were identified in 2022- while more than three million went undetected and untreated. The low detection rate illustrates the failure to recognise and diagnose TB in the current cascade of healthcare and is a major obstacle to effective TB control programs. This multi-centre cluster-randomised clinical trial will evaluate the effect (i.e., diagnostic yield) of improving the point-of-care diagnostics already in place in most primary health-care centres in low-resource settings. The present study will be conducted in two different geographical settings in the Western and Eastern African countries of Guinea Bissau and Ethiopia. This improved clinical diagnostic pathway may improve case detection rates at primary healthcare level, ensuring prompt commencement of treatment, thereby diminishing transmission risk in the community and improving treatment outcomes. The Optimized Diagnostic Procedure (ODP) will utilize instructed sputum sampling and pooling as well as computer-aided detection (CAD) chest X-ray (CXR) and additional pooled sputum sample as well as non-sputum sampling (faecal and a buccal/tongue swab and saliva) for GeneXpert Ultra PCR (Xpert) as state-of-the-art add-ons to the routine diagnostic pathway for TB. This adds to the key components of the WHO "End TB" strategy - early diagnosis - and if successful, may be rapidly approved by the WHO and implemented by governments globally with potentially major public health benefits. The study will be conducted in close liaison with the national Ministries of Health and TB programs in Guinea-Bissau and Ethiopia. This will facilitate any relevant findings to be taken forward for implementation into policy and practice. Capacity development, training and educational activities will be closely aligned to this study.
Eligibility Criteria
Inclusion Criteria: * ≥15 years old * presumed TB with cough, sputum production, and/or weight loss of any duration Exclusion Criteria: * TB treatment within the past year. * Cerebral disturbances impairing the ability to give informed consent or follow the treatment regime.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06437184 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 120 Years, studying Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06437184 currently recruiting?
Yes, NCT06437184 is actively recruiting participants. Contact the research team at frauke.rudolf@au.dk for enrollment information.
Where is the NCT06437184 trial being conducted?
This trial is being conducted at Gonder, Ethiopia, Bissau, Guinea-Bissau.
Who is sponsoring the NCT06437184 clinical trial?
NCT06437184 is sponsored by Aarhus University Hospital. The trial plans to enroll 1,584 participants.