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

NCT ID: NCT00557765

Last Updated: 2007-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

295 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tuberculosis Latent Tuberculosis Infection

Keywords

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Tuberculosis Latent tuberculosis infection Interferon gamma release assay Contact tracing

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ligue Pulmonaire Genevoise

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Principal Investigators

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Jean-Paul Janssens, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centre antituberculeux

Locations

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Centre antituberculeux; Geneva University Hospital

Geneva, Canton of Geneva, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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04-184

Identifier Type: -

Identifier Source: org_study_id