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NCT Number: NCT06485895

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, France

Location status: Recruiting

Location contact

ALEXANDRA GIULIANI

CONTACT

[email protected]

PIERRE-EDOUARD FOURNIER

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

test IGRA

Diagnostic Test

BLOOD SAMPLES

TEST QUATIFERON TB Gold Plus

Diagnostic Test

BLOOD SAMPLES

Primary outcomes

  1. sensitivity of TB-IGRA 2nd generation test

    Time frame: 24 MONTHS

  2. specificity of TB-IGRA 2nd generation test

    Time frame: 24 MONTHS

Study contacts

Contact information is provided by the study sponsor or research team.

ALEXANDRA GIULIANI PROJECT MANAGER

CONTACT

[email protected]

PR PIERRE EDOUARD FOURNIER PU-PH

CONTACT

[email protected]

33+ 04 13 73 24 31

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: TUBIGRA

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 3, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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