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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: TUBERCULOSIS

Treatments: Diagnostic Test: TEST QUATIFERON TB Gold Plus; Diagnostic Test: test IGRA

Study type: Interventional

Funder types: Other

Identifiers

NCT06485895

RCAPHM24_0100

2024-A00322-45 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

TUBERCULOSIS (LATENTE OR ACTIVE) ARM

Experimental group

Treatment:

Diagnostic Test: test IGRA

Diagnostic Test: TEST QUATIFERON TB Gold Plus