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

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.

Study Overview

• Status: Recruiting
• Conditions: TUBERCULOSIS
• Intervention / Treatment: Diagnostic test: test IGRA; Diagnostic test: TEST QUATIFERON TB Gold Plus

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PR PIERRE EDOUARD FOURNIER PU-PH; Phone Number: 33+ 04 13 73 24 31; Email: pierre-edouard.fournier@ap-hm.fr
• Study Contact Backup: Name: ALEXANDRA GIULIANI PROJECT MANAGER; Email: alexandra.giuliani@ap-hm.fr

Study Locations

• France
  • Marseille, France
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: ALEXANDRA GIULIANI; Email: alexandra.giuliani@ap-hm.fr
    • Principal Investigator: PIERRE-EDOUARD FOURNIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TUBERCULOSIS (LATENTE OR ACTIVE) ARM	Diagnostic test: test IGRA; BLOOD SAMPLES; Diagnostic test: TEST QUATIFERON TB Gold Plus; BLOOD SAMPLES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
sensitivity of TB-IGRA 2nd generation test	24 MONTHS
specificity of TB-IGRA 2nd generation test	24 MONTHS

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, ASSISTANCE PUBLIQUE HOPITAUX D EMARSEILLE

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: RCAPHM24_0100; 2024-A00322-45 (Other Identifier: N°IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No