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Use of a Gamma-IFN Assay in Contact Tracing for Tuberculosis in a Low-Incidence, High Immigration Area

Sponsor
University Hospital, Geneva (Other)
Overall Status
Completed
CT.gov ID
NCT00557765
Collaborator
Ligue Pulmonaire Genevoise (Other)
295
Enrollment
1
Location
15
Duration (Months)
19.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

After exposure to an active case of tuberculosis (TB), close contacts may be infected. They are then considered as having latent tuberculosis infection (LTBI). Detecting LTBI is the main goal of contact tracing procedures after exposure to TB. Until recently, the only test available for detecting LTBI was the tuberculin skin test (TST). More recent tests are now available (Interferon-gamma release assays: IGRA), which are more specific and sensitive than the TST. This study compares the TST and an IGRA in the routine activity of contact tracing in our area.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Setting: A TB clinic in Geneva, Switzerland, a low incidence area for TB with a high immigrant population.

    Aim of study: to compare results of an IGRA test (T-SPOT.TB, Oxford Immunotec, UK) and the TST, and their correlation with exposure scores in subjects exposed to cases of contagious TB.

    Methods: Prospective study of all contacts screened in our area, and accepting to be included. Simultaneous recording of age, gender, origin, history of recent travels or exposure, BCG vaccination status, infectiousness of index case, 5 different exposure scores, TST, and result of the T-SPOT.TB blood test. Univariate and multivariate analysis.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    295 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Production of Gamma-Interferon by Circulating Lymphocytes Exposed to Antigens Specific of Mycobacterium Tuberculosis: Contribution to the Identification of Latent Tuberculosis Infection in Contact Tracing
    Study Start Date :
    Oct 1, 2004
    Actual Study Completion Date :
    Jan 1, 2006

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between results of TST and IGRA tests and exposure scores [2 months after exposure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Exposure to a case of contagious TB

    • Willingness to participate in study

    Exclusion Criteria:

    • Known HIV infection

    • Known previous TB or treatment for LTBI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre antituberculeux; Geneva University Hospital Geneva Switzerland 1211

    Sponsors and Collaborators

    • University Hospital, Geneva
    • Ligue Pulmonaire Genevoise

    Investigators

    • Principal Investigator: Jean-Paul Janssens, M.D., Centre antituberculeux

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00557765
    Other Study ID Numbers:
    • 04-184
    First Posted:
    Nov 14, 2007
    Last Update Posted:
    Nov 14, 2007
    Last Verified:
    Nov 1, 2007
    Keywords provided by , ,
    Tuberculosis
    Latent tuberculosis infection
    Interferon gamma release assay
    Contact tracing
    Additional relevant MeSH terms:
    Infections
    Tuberculosis
    Latent Tuberculosis

    Study Results

    No Results Posted as of Nov 14, 2007