Improving tuberculosis case detection in low-resource settings
Official title: Increased Tuberculosis Case Detection - a Cluster-randomized Trial Combining Available Resources and Novel Strategies for High Endemic Areas
Run by Aarhus University Hospital · NCT06437184 · Data updated 2026-11-12
This study is testing two different ways to find tuberculosis in healthcare centers in Guinea Bissau and Ethiopia to see which one helps diagnose and treat patients faster.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years to 120 Years |
| Sex | All |
| Enrollment | 1584 (estimated) |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 2 sites (Gonder and 1 other locations) |
| Status | Recruiting |
| Started | June 3, 2024 |
| Main results expected | October 30, 2025 |
| Study ends | March 31, 2026 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT06437184 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 15 and older who exhibit symptoms of tuberculosis, such as cough, sputum production, or weight loss.
✕Probably not a fit
Patients who have received TB treatment within the past year or have cerebral disturbances that impair their ability to consent or follow treatment will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to enhance the detection of tuberculosis (TB) in primary healthcare centers in low-resource settings by comparing two diagnostic procedures: the Enhanced Usual Diagnostic Procedure (EUDP) and the Optimized Diagnostic Procedure (ODP). Conducted in Guinea Bissau and Ethiopia, the trial will assess the diagnostic yield of active TB within ten days and the number of patients treated for TB within two weeks. It will also evaluate the effectiveness of various diagnostic methods, including the use of Oxford Nanopore sequencing for detecting TB and its resistance patterns. The goal is to improve case detection rates, initiate prompt treatment, and ultimately reduce TB transmission in the community.
Why it matters
Potential benefit: If successful, this study could significantly increase the early detection and treatment of tuberculosis, leading to better health outcomes and reduced transmission rates.
How similar studies have gone: Previous studies have shown that improving diagnostic procedures can reduce diagnostic delays, but this specific approach is novel in its focus on optimizing diagnostics in low-resource settings.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Gondar University
Gonder, Ethiopia Recruiting -
Projecto Saude de Bandim
Bissau, Guinea-Bissau Recruiting
Study contacts
- Study coordinator: Frauke Rudolf
- Email: frauke.rudolf@au.dk
- Phone: 51372359
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Doxycycline added to standard treatment for central nervous system tuberculosis
This trial tests whether adding doxycycline to standard anti‑TB therapy and corticosteroids helps adults with central nervous system tuberculosis live longer or have less severe neurological disability.
-
Biomarker Test for Diagnosis and Monitoring of Extrapulmonary Tuberculosis
This study tests biomarker-based methods to help diagnose extrapulmonary TB and monitor treatment in adults, including people living with HIV, using samples from affected sites in Kenya.
-
Short-Course TB Treatment for Children with Non-Severe Pulmonary TB
This trial tests two shorter-treatment options for kids with non-severe pulmonary TB to see if they can clear the infection as well as the standard 6-month plan.
-
Combined oral contraceptive timing with Ganfeborole in healthy women
This study tests how the contraceptive Microgynon behaves in the body when given alone and with Ganfeborole in healthy women who can’t get pregnant.
-
Isoniazid inhalation in TB patients: a first-in-human look at local tolerability and body levels
This early study tests inhaled isoniazid to see how well it tolerates the lungs and how it behaves in the body in adults with tuberculosis.
-
How the immune system responds to mycobacterial infections
This study tests how the immune system changes in people with tuberculosis and related mycobacterial infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.