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Active, Not Recruiting

NCT Number: NCT05724212

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinical symptoms consistent with a high probability of having PULMONARY TB disease (probable case), such that they are receiving or are likely to receive ther-apy for active PTB (therapy must not have been initiated for more than 72 hours before recruitment into the study).
  • Positive sputum smear for AAR
  • Positive culture for mycobacterium tuberculosis (confirmed PTB case).
  • Positive nucleic acid amplification (NAA) test for mycobacterium tuberculosis.

Exclusion criteria

  • Taken therapy for active tuberculosis or latent TB infection for more than 72 hours.
  • Culture confirmation of M. tuberculosis not obtained.
  • Age less than 18 years.
  • Immunosuppression: HIV-infection, solid organ transplantation, stem cell transplantation, rheumatoid arthritis.

Treatment and study plan

Interferon gamma release assay (IGRA)

Diagnostic Test

in vitro test

Primary outcomes

  1. Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for monitoring anti-Tuberculosis treatment

    Time frame: 1. At time of diagnosis (t0) 2. 30+ 4 days after anti-TB treatment initiation (t1) 3. 2 months after anti-TB treatment initiation (t2) 4. At the end of the anti-TB therapy (6 to 9 months) (t3)

    Define the degree of correlation between changes in IFN-γ response in the first antigen tube (TB1) and the newly added antigen tube (TB2) and the reference stand-ard of treatment response (culture conversion) in smear-positive and smear-negative/culture-positive pulmonary TB cases

Sponsors and collaborators

Lead sponsor

Paola Mantegani

Other

Registry information

Acronym: IGRA/MAT-1

Important dates

Study start
2017
Primary completion
2021
Study completion
2025
First posted
Feb 13, 2023
Registry last updated
Sep 26, 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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