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

Last updated: July 31, 2024
Sponsor: Assistance Publique Hopitaux De Marseille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

TEST QUATIFERON TB Gold Plus

test IGRA

Clinical Study ID

NCT06485895
RCAPHM24_0100
2024-A00322-45
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 medicallyprescribed 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

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

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: TEST QUATIFERON TB Gold Plus
Phase:
Study Start date:
July 30, 2024
Estimated Completion Date:
February 01, 2028

Study Description

It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects

Connect with a study center

  • Assistance Publique Hopitaux de Marseille

    Marseille,
    France

    Active - Recruiting

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