Clinical trial Recruiting at 2 sites Interventional Ages 15 to 120

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 typeInterventional
Ages15 Years to 120 Years
SexAll
Enrollment1584 (estimated)
SponsorAarhus University Hospital
Academic / other
Locations2 sites (Gonder and 1 other locations)
StatusRecruiting
StartedJune 3, 2024
Main results expectedOctober 30, 2025
Study endsMarch 31, 2026
Registry record updatedOctober 3, 2025
Trial IDNCT06437184 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.