New Generation IGRA in Immunocompromised Individuals (TBnet#54)

August 5, 2016 updated by: 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

Unknown

Conditions

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

Observational

Enrollment (Anticipated)

2000

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 Locations

  • Denmark
      • Kopenhagen, Denmark, 2100
  • Germany
  • Italy
      • Brescia, Italy
        • Recruiting
        • University of Brescia and Brescia Spedali Civili General Hospital
        • Contact:
      • Milano, Italy, 20132
        • Recruiting
        • San Raffaele Scientific Institute
        • Contact:
      • Rome, Italy, 00149
        • Recruiting
        • National Institute for Infectious Diseases L. Spallanzani
        • Contact:
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2004
        • Not yet recruiting
        • Department of Pneumology & Allergology
        • Contact:
  • Norway
      • Oslo, Norway, 0450
        • Recruiting
        • Department of Infectious Diseases; Oslo University
        • Contact:
  • Poland
  • Portugal
      • Vila Nova de Gaia, Portugal
        • Recruiting
        • Centro de Diagnóstico Pneumológico
        • Contact:
  • Romania
    • Sector 5
      • Bucharest, Sector 5, Romania, 5
        • Recruiting
        • Marius Nasta Institute of Pneumology
        • Contact:
  • Spain
      • Badalona, Spain, 08916
        • Not yet recruiting
        • Institut d'Investigació Germans Trias i Pujol
        • Contact:
        • Sub-Investigator:
          • Neus Altet, MD
      • Barcelona, Spain, 08001
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Oviedo, Spain, 33001
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Department of Respiratory Medicine, Royal Free Hospital
        • Contact:
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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
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

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

Tuberculosis Network European Trialsgroup

Investigators

  • Principal Investigator: Martina Sester, PhD, Universität des Saarlandes

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

December 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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