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Completed

NCT Number: NCT02639936

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

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Key information

Conditions

Monitoring, Immunologic Actinomycetales Infections Active Tuberculosis Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis Tuberculosis in Chronic Renal Failure Tuberculosis in HIV-infected Individuals Tuberculosis in Marrow Transplant Recipients Tuberculosis in Rheumatoid Arthritis Tuberculosis in Solid Organ Transplant Recipients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • <18 years of age

Treatment and study plan

Primary outcomes

  1. 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. Sensitivity

    Time frame: 2 years

    The percentage of positive test results will be quantified among controls and patients with active tuberculosis.

  3. Indeterminate results

    Time frame: 2 years

    The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients

  4. Association with exposure

    Time frame: 2 years

    Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure

  5. 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

Sponsors and collaborators

Lead sponsor

Tuberculosis Network European Trialsgroup

Network

Registry information

Official study title

Performance of a New Generation IGRA in Immunocompromised Individuals

Acronym: TBnet#54

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Dec 28, 2015
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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