Evaluating a new test for diagnosing tuberculosis
Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
NA · Assistance Publique Hopitaux De Marseille · NCT06485895
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06485895 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, breastfeeding, or currently incarcerated will not benefit from this study.
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 performed: Other studies have shown promising results with IGRA tests for tuberculosis diagnosis, indicating that this approach is supported by existing research.
Eligibility criteria
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 this trial is running
Marseille
- 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
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