Improving tuberculosis case detection in low-resource settings
Increased Tuberculosis Case Detection - a Cluster-randomized Trial Combining Available Resources and Novel Strategies for High Endemic Areas
NA · Aarhus University Hospital · NCT06437184
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1584 (estimated) |
| Ages | 15 Years to 120 Years |
| Sex | All |
| Sponsor | Aarhus University Hospital (other) |
| Locations | 2 sites (Gonder and 1 other locations) |
| Trial ID | NCT06437184 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gonder and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tuberculosis