Evaluating a new test for diagnosing tuberculosis
Official title: Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Run by Assistance Publique Hopitaux De Marseille · NCT06485895 · Data updated 2026-11-12
This study is testing a new tuberculosis test to see if it can accurately diagnose both active and latent cases in patients seeking treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | July 30, 2024 |
| Main results expected | July 30, 2027 |
| Study ends | February 1, 2028 |
| Registry record updated | August 1, 2024 |
| Trial ID | NCT06485895 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are French-speaking adults aged 18 and older who are being treated for tuberculosis and have undergone a reference IGRA test.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or currently incarcerated 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 study aims to assess the performance of a second-generation IGRA test in diagnosing both active and latent tuberculosis. It will involve 500 patients who are presenting for tuberculosis treatment and have undergone a medically prescribed reference IGRA test. The study will measure the sensitivity and specificity of the new test to ensure accurate diagnosis. The results will help determine the effectiveness of this test in routine patient care.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and reliable diagnosis of tuberculosis, improving patient outcomes.
How similar studies have gone: Other studies have shown promising results with IGRA tests for tuberculosis diagnosis, indicating that this approach is supported by existing research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individual at least 18 years of age * Patient presenting for treatment of tuberculosis disease * Having undergone or benefiting from screening for tuberculosis using a medically prescribed reference IGRA test. * Informed patient who has not expressed opposition to participating in the study. French-speaking patient with unambiguous understanding of oral and written instructions. Exclusion Criteria: Persons in a period of exclusion from another study * Pregnant, parturient or breast-feeding women; * Person deprived of liberty by judicial or administrative decision
Where it's running
-
Assistance Publique Hopitaux de Marseille
Marseille, France Recruiting
Study contacts
- Study coordinator: Pr Pierre Edouard Fournier Pu-Ph
- Email: pierre-edouard.fournier@ap-hm.fr
- Phone: 33+ 04 13 73 24 31
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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.