Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorAssistance Publique Hopitaux De Marseille
Academic / other
Locations1 site (Marseille)
StatusRecruiting
StartedJuly 30, 2024
Main results expectedJuly 30, 2027
Study endsFebruary 1, 2028
Registry record updatedAugust 1, 2024
Trial IDNCT06485895 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

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.