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ACTIVE NOT RECRUITING
NCT05724212

Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment

Sponsor: Paola Mantegani

View on ClinicalTrials.gov

Summary

Evaluate the possibility of using an IGRA (Interferon-γ Release Assay) test for monitoring the response to anti-tuberculosis therapy by studying the correlation between the variation in the Interferon-gamma (IFN-γ) response to the QFT-Plus test in the two tubes containing antigens and the gold standard for monitoring TB therapy (culture conversion) in patients with slide positive/culture positive and slide negative/culture positive PTB. Evaluate the level of agreement between the results of the new QFT Access test and the results of the QFT plus and culture in patients diagnosed with active tuberculosis. To evaluate the level of agreement between QFT Access test results and QFT Plus results in healthy controls and contacts.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2017-01-27

Completion Date

2025-02-01

Last Updated

2024-09-26

Healthy Volunteers

Yes

Conditions

Interventions

DIAGNOSTIC_TEST

Interferon gamma release assay (IGRA)

in vitro test

Locations (1)

IRCCS San Raffaele Scientific Institute

Milan, Italy