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Recruiting Not applicable

Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis

NCT06485895 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-07-30
Last updated
2024-08-01

Condition(s) studied

TUBERCULOSIS

Investigational drug(s) / intervention(s)

test IGRATEST QUATIFERON TB Gold Plus

test IGRA: BLOOD SAMPLES

TEST QUATIFERON TB Gold Plus: BLOOD SAMPLES

Study summary

Methodology This is a single-center study carried out as part of routine patient care.

The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • sensitivity of TB-IGRA 2nd generation test — 24 MONTHS
  • specificity of TB-IGRA 2nd generation test — 24 MONTHS

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique Hopitaux de Marseille Marseille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06485895 on ClinicalTrials.gov ↗ ← All trials in France