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

NCT05724212 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2024-09-26

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Interferon gamma release assay (IGRA)

in vitro test

Sponsors & Collaborators

  • Paola Mantegani

    lead OTHER

Principal Investigators

  • Daniela M Cirillo, MD,PhD · IRCCS San Raffaele Scientific Institute Via Olgettina 60 20132 Milan Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-27
Primary Completion
2021-05-13
Completion
2025-02-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05724212 on ClinicalTrials.gov