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

Not Applicable

Recruiting

• Conditions: TUBERCULOSIS
• Interventions: Diagnostic Test: test IGRA; Diagnostic Test: TEST QUATIFERON TB Gold Plus

• Registration Number: NCT06485895
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2024-06-26
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-02
• Study First Posted: 2024-07-03
• Study Start: 2024-07-30
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2027-07-30
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TUBERCULOSIS (LATENTE OR ACTIVE) ARM	TEST QUATIFERON TB Gold Plus	-
TUBERCULOSIS (LATENTE OR ACTIVE) ARM	test IGRA	-

Primary Outcome Measures

Name	Time	Method
sensitivity of TB-IGRA 2nd generation test	24 MONTHS
specificity of TB-IGRA 2nd generation test	24 MONTHS

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France