Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment (IGRA/MAT-1)

Paola Mantegani

Status: Active, not recruiting

Conditions: Tuberculosis

Treatments: Diagnostic Test: Interferon gamma release assay (IGRA)

Study type: Observational

Funder types: Other

Identifiers

NCT05724212

IGRA/MAT-1

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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).
2. Positive sputum smear for AAR
3. Positive culture for mycobacterium tuberculosis (confirmed PTB case).
4. Positive nucleic acid amplification (NAA) test for mycobacterium tuberculosis.

Exclusion criteria

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

Trial design

220 participants in 2 patient groups

Control Group (healthy subject)

Treatment:

Diagnostic Test: Interferon gamma release assay (IGRA)

Subject with Pulmonary Tuberculosis (PTB)

Treatment:

Diagnostic Test: Interferon gamma release assay (IGRA)