New Generation IGRA in Immunocompromised Individuals (TBnet#54)

April 7, 2025 updated by: Martina Sester, PhD, Tuberculosis Network European Trialsgroup

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2663

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Kopenhagen, Denmark, 2100
        • Rigshospitalet
  • Germany
      • Borstel, Germany
        • Research Center Borstel
      • Freiburg, Germany, 79100
        • Freiburg University
      • Homburg, Germany, 66421
        • Saarland University
  • Italy
      • Brescia, Italy
        • University of Brescia and Brescia Spedali Civili General Hospital
      • Milano, Italy, 20132
        • San Raffaele Scientific Institute
      • Rome, Italy, 00149
        • National Institute for Infectious Diseases L. Spallanzani
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2004
        • Department of Pneumology & Allergology
  • Norway
      • Oslo, Norway, 0450
        • Department of Infectious Diseases; Oslo University
  • Poland
      • Warszawa, Poland, 02-097
        • Warszawski Uniwersytet Medyczny
  • Portugal
      • Vila Nova de Gaia, Portugal
        • Centro de Diagnóstico Pneumológico
  • Romania
    • Sector 5
      • Bucharest, Sector 5, Romania, 5
        • Marius Nasta Institute of Pneumology
  • Spain
      • Badalona, Spain, 08916
        • Institut d'Investigació Germans Trias i Pujol
      • Barcelona, Spain, 08001
        • Hospital Universitari Vall d'Hebron
      • Oviedo, Spain, 33001
        • Hospital Universitario Central de Asturias
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Department of Respiratory Medicine, Royal Free Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Immunocompetent and immunocompromised patients

Description

Inclusion Criteria:

  • Individuals as specified for the study Population
  • Written informed consent

Exclusion Criteria:

  • <18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years
Sensitivity
Time Frame: 2 years
The percentage of positive test results will be quantified among controls and patients with active tuberculosis.
2 years
Indeterminate results
Time Frame: 2 years
The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients
2 years
Association with exposure
Time Frame: 2 years
Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure
2 years
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tuberculosis Network European Trialsgroup

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martina Sester, PhD, Universität des Saarlandes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TBnet study #54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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