TuberculosisIGRA/MAT-1NCT05724212
Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment
An observational study of Tuberculosis, run by Paola Mantegani at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Interferon gamma release assay (IGRA)
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2017to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: San Raffaele Hospital wards
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Tuberculosis
- Being tested
- Interferon gamma release assay (IGRA)
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon gamma release assay (IGRA)Diagnostic test
in vitro test
| Study group | Role | What they receive |
|---|---|---|
| Control Group (healthy subject) | Not described Receives: Diagnostic Test: Interferon gamma release assay (IGRA) | |
| Subject with Pulmonary Tuberculosis (PTB) | Not described Receives: Diagnostic Test: Interferon gamma release assay (IGRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for monitoring anti-Tuberculosis treatment
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start27 Jan 2017
- Primary completion13 May 2021
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paola Mantegani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paola Mantegani, Ospedale San Raffaele
- Investigators
- Daniela M Cirillo, MD,PhD, Principal investigator, IRCCS San Raffaele Scientific Institute Via Olgettina 60 20132 Milan Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724212
- Sponsor's protocol ID
- IGRA/MAT-1
- Acronym
- IGRA/MAT-1
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment
- ClinicalTrials.gov ID
- NCT05724212
- Acronym / sponsor ID
- IGRA/MAT-1 / IGRA/MAT-1
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Paola ManteganiUniversity, hospital or other
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (healthy subject) | – | Diagnostic Test: Interferon gamma release assay (IGRA) |
| Subject with Pulmonary Tuberculosis (PTB) | – | Diagnostic Test: Interferon gamma release assay (IGRA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- San Raffaele Hospital wards
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon gamma release assay (IGRA)in vitro test | Diagnostic test | Control Group (healthy subject), Subject with Pulmonary Tuberculosis (PTB) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela M Cirillo, MD,PhD principal investigator
IRCCS San Raffaele Scientific Institute Via Olgettina 60 20132 Milan Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Paola Mantegani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.