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

Tuberculosis Clinical Trial

— IGRA/MAT-1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05724212
• Other study ID #: IGRA/MAT-1
• Status: Active, not recruiting
• Start date: January 27, 2017
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: February 1, 2024
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Diagnostic Test:
• Interferon gamma release assay (IGRA)
in vitro test

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Scientific Institute	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Paola Mantegani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for monitoring anti-Tuberculosis treatment	Define the degree of correlation between changes in IFN-? 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	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)