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

Active, not recruiting

• Conditions: Tuberculosis
• Interventions: Diagnostic Test: Interferon gamma release assay (IGRA)

• Registration Number: NCT05724212
• Lead Sponsor: Paola Mantegani

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-27
• Primary Completion: 2021-05-13
• Status Verified: 2023-02
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group (healthy subject)	Interferon gamma release assay (IGRA)	-
Subject with Pulmonary Tuberculosis (PTB)	Interferon gamma release assay (IGRA)	-

Primary Outcome Measures

Name	Time	Method
Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for monitoring anti-Tuberculosis treatment	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

Trial Locations

Locations (1)

IRCCS San Raffaele Scientific Institute; 🇮🇹 Milano, Italy