Performance of IGRAs for TB Infection Diagnosis in Elderly (IGRage)

May 27, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Mycobacterium Tuberculosis Infection Diagnosis in Patients Above 75 Years Old/ Performance of Interferon Gamma Releasing Assays (IGRA)

Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context.

TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In vitro Interferon Gamma releasing Assay (IGRA) are recommended for LTBI screening as or instead of TST, but there accuracy in those old patients are not known: as immune responses are impaired in elderly and some of them have already met M tuberculosis before active antibiotherapy exists.The aim of this study is to evaluate characteristics of the two commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in tube® and TST in old patients with or without active Tuberculosis.

Principal outcome:

- 3 tests performance for active TB diagnosis in patients older than 75 years-old

Secondary outcomes :

  • concordance between IGRAs.
  • non-concordant results analysis
  • concordance of IGRAs results with time of TB-infection
  • biobank

Methodology :Diagnostic test performance study

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

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

Study Locations

  • France
      • Bondy, France, 93143
        • Service de Médecine Interne
      • Paris, France, 75013
        • Servive de Médecine Interne (Pr S. Herson)
      • Strasbourg, France, 67000
        • Service de Médecine Interne, Diabete et Maladies Métaboliques

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected tuberculosis disease

Description

Inclusion Criteria:

  • Age > 75 years
  • Consent signed
  • hospitalized patient with start treatment of Tuberculosis disease
  • French social right

Exclusion Criteria:

  • Tuberculosis disease treatment since 7 days
  • No 3 months follow-up possible
  • Immunosuppression

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active TB-infected patients
TB-infected patients with bacteriological and histological evidences
Other: Blood samples

4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)

1 blood dry tube (5ml)
Non active TB-infected patients (already met TB)
some of elders have already met M tuberculosis before active antibiotherapy exists
Other: Blood samples

4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)

1 blood dry tube (5ml)
Non active TB-infected patients (other diagnosis)
same symptoms than two others groups but an other diagnosis
Other: Blood samples

4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)

1 blood dry tube (5ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of positive, indeterminate, negative tests in each group
Time Frame: month27
month27

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test results in clinical LTBI patients
Time Frame: month 27
month 27
Correlation with TB-infection date
Time Frame: month 27
Test results (positive/negative) according to LTBI date
month 27
Blood samples collection in order to test new hypothesis in patients with non-concordant results
Time Frame: month 27
month 27
Performance comparison between tests (T-SPOT.TB®, Quantiferon-Gold-IT®)
Time Frame: month 27
month 27

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Guislaine CARCELAIN, MD, Assistance Publique - Hôpitaux de Paris

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)

July 17, 2013

Primary Completion (Actual)

March 17, 2019

Study Completion (Actual)

March 17, 2019

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

July 5, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110131
  • 2012-A00326-37 (Other Identifier: ANSM)

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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