Monitoring, ImmunologicTBnet#54NCT02639936
New Generation IGRA in Immunocompromised Individuals
An observational study of Monitoring, Immunologic and Active Tuberculosis, run by Tuberculosis Network European Trialsgroup at 16 sites in 10 countries.
Trial summary
Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monitoring, Immunologic, Active Tuberculosis, Tuberculosis in Solid Organ Transplant Recipients
- How many people
- 2,663 participants
- Where
- 16 sitesin 10 countries
- Study dates
- Dec 2015to Dec 2023
- 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: Immunocompetent and immunocompromised patients
Who may be able to join
- Individuals as specified for the study Population
- Written informed consent
Who cannot join
- <18 years of age
Trial locations and contacts
16 sites in 10 countries.
16 sites in 10 countries
Germany3 sites
Research center Borstel
Borstel
Freiburg University
Freiburg im Breisgau, 79100
Saarland University
Homburg, 66421
Italy3 sites
University of Brescia and Brescia Spedali Civili General Hospital
Brescia
San Raffaele Scientific institute
Milan, 20132
National Institute for Infectious Diseases L. Spallanzani
Rome, 00149
Spain3 sites
Institut d'Investigació Germans Trias i Pujol
Badalona, 08916
Hospital Universitari Vall d'Hebron
Barcelona, 08001
Hospital Universitario Central de Asturias
Oviedo, 33001
United Kingdom1 site
Department of Respiratory Medicine, Royal Free Hospital
London, NW3 2QG
About this study
Official title: Performance of a New Generation IGRA in Immunocompromised Individuals
Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients
Read the detailed description
This study is designed to evaluate the performance of a new ELISA based QuantiFERON-TB plus In-tube test to identify M. tuberculosis specific immune Responses as evidence of latent infection with M. tuberculosis in immunosuppressed populations. Both qualitative and quantitative test results will be related to the level of immunodeficiency and to the presence of risk factors for prior exposure with M. tuberculosis. In addition, patients with active tuberculosis (both immunocompetent and immunocompromised individuals) will be included to evaluate a potential increase in sensitivity in these groups. Immunocompetent individuals with low risk of exposure will be analysed as a proxy to estimate specificity. Finally, this study will be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.
- Conditions
- Monitoring, Immunologic, Active Tuberculosis, Tuberculosis in Solid Organ Transplant Recipients, Tuberculosis in Marrow Transplant Recipients, Tuberculosis in Rheumatoid Arthritis, Tuberculosis in Chronic Renal Failure
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immunocompetent controls | Control persons without immunodeficiency with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | |
| Solid organ transplant recipients | Patients after solid organ transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | |
| Stem cell transplant recipients | Patients after stem cell transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | |
| Patients with rheumatoid arthritis | Patients with rheumatoid arthritis with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | |
| Patients with chronic renal failure | Patients with chronic renal failure with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | |
| Individuals with HIV infection | Individuals with HIV infection with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity
The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure.
Measured: 2 years
Sensitivity
The percentage of positive test results will be quantified among controls and patients with active tuberculosis.
Measured: 2 years
Indeterminate results
The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients
Measured: 2 years
Association with exposure
Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure
Measured: 2 years
Progression
The number of individuals progressing to tuberculosis will be quantified depending on the test result at the time of screening and depending on preventive chemotherapy
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Monitoring, ImmunologicStudies 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
- 2,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuberculosis Network European Trialsgroup
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Martina Sester, PhD, Tuberculosis Network European Trialsgroup
- Investigators
- Martina Sester, PhD, Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639936
- Sponsor's protocol ID
- TBnet study #54
- Acronym
- TBnet#54
- Status last verified
- Apr 2025
- First submitted
- 15 Dec 2015
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Sester M, Altet-Gomez N, Andersen AB, Arias-Guillen M, Avsar K, Bakken Kran AM, Bothamley G, Nordholm Breschel AC, Brown J, Chesov D, Ciobanu N, Cirillo DM, Crudu V, de Souza Galvao M, Dilektasli AG, Dominguez J, Duarte R, Dyrhol-Riise AM, Goletti D, Hoffmann H, Ibraim E, Kalsdorf B, Krawczyk M, Kunst H, Lange B, Lipman M, Matteelli A, Milkiewicz P, Neyer D, Nitschke M, Oral HB, Palacios-Gutierrez JJ, Petruccioli E, Raszeja-Wyszomirska J, Ravn P, Rupp J, Spohn HE, Toader C, Villar-Hernandez R, Wagner D, van Leth F, Martinez L, Pedersen OS, Lange C. Diagnostic accuracy and predictive value of the QuantiFERON-TB gold plus assay for tuberculosis in immunocompromised individuals: a prospective TBnet study. Lancet Reg Health Eur. 2025 Aug 6;57:101416. doi: 10.1016/j.lanepe.2025.101416. eCollection 2025 Oct.
PubMed 40823191
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of a New Generation IGRA in Immunocompromised Individuals
- ClinicalTrials.gov ID
- NCT02639936
- Acronym / sponsor ID
- TBnet#54 / TBnet study #54
- Conditions
- Monitoring, Immunologic, Active Tuberculosis, Tuberculosis in Solid Organ Transplant Recipients, Tuberculosis in Marrow Transplant Recipients, Tuberculosis in Rheumatoid Arthritis, Tuberculosis in Chronic Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,663 participants (actual)
- Lead sponsor
- Tuberculosis Network European TrialsgroupResearch network
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 28 Dec 2015 (estimated)
- 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.
Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients
Detailed description
This study is designed to evaluate the performance of a new ELISA based QuantiFERON-TB plus In-tube test to identify M. tuberculosis specific immune Responses as evidence of latent infection with M. tuberculosis in immunosuppressed populations. Both qualitative and quantitative test results will be related to the level of immunodeficiency and to the presence of risk factors for prior exposure with M. tuberculosis. In addition, patients with active tuberculosis (both immunocompetent and immunocompromised individuals) will be included to evaluate a potential increase in sensitivity in these groups. Immunocompetent individuals with low risk of exposure will be analysed as a proxy to estimate specificity. Finally, this study will be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Immunocompetent controls | – | –Control persons without immunodeficiency with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis |
| Solid organ transplant recipients | – | –Patients after solid organ transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis |
| Stem cell transplant recipients | – | –Patients after stem cell transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis |
| Patients with rheumatoid arthritis | – | –Patients with rheumatoid arthritis with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis |
| Patients with chronic renal failure | – | –Patients with chronic renal failure with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis |
| Individuals with HIV infection | – | –Individuals with HIV infection with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Immunocompetent and immunocompromised patients
Key inclusion criteria (2 listed)
- Individuals as specified for the study Population
- Written informed consent
Key exclusion criteria (1 listed)
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specificity
Time frame: 2 years
The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure.
Sensitivity
Time frame: 2 years
The percentage of positive test results will be quantified among controls and patients with active tuberculosis.
Indeterminate results
Time frame: 2 years
The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients
Association with exposure
Time frame: 2 years
Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure
Progression
Time frame: 4 years
The number of individuals progressing to tuberculosis will be quantified depending on the test result at the time of screening and depending on preventive chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 40823191Sester M, Altet-Gomez N, Andersen AB, Arias-Guillen M, Avsar K, Bakken Kran AM, Bothamley G, Nordholm Breschel AC, Brown J, Chesov D, Ciobanu N, Cirillo DM, Crudu V, de Souza Galvao M, Dilektasli AG, Dominguez J, Duarte R, Dyrhol-Riise AM, Goletti D, Hoffmann H, Ibraim E, Kalsdorf B, Krawczyk M, Kunst H, Lange B, Lipman M, Matteelli A, Milkiewicz P, Neyer D, Nitschke M, Oral HB, Palacios-Gutierrez JJ, Petruccioli E, Raszeja-Wyszomirska J, Ravn P, Rupp J, Spohn HE, Toader C, Villar-Hernandez R, Wagner D, van Leth F, Martinez L, Pedersen OS, Lange C. Diagnostic accuracy and predictive value of the QuantiFERON-TB gold plus assay for tuberculosis in immunocompromised individuals: a prospective TBnet study. Lancet Reg Health Eur. 2025 Aug 6;57:101416. doi: 10.1016/j.lanepe.2025.101416. eCollection 2025 Oct.
- TBnet websiteLink provided by the sponsor.
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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.
Martina Sester, PhD principal investigator
Universität des Saarlandes
16 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring, Immunologic and Active Tuberculosis, run by Tuberculosis Network European Trialsgroup at 16 sites in 10 countries.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Italy, Spain, Denmark, Moldova and 5 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Specificity (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639936, which also lists 1 linked publication.
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 10 Apr 2025.