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

Sponsors and Collaborators:	University Hospital, Geneva Ligue Pulmonaire Genevoise
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00557765

Purpose

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
Tuberculosis Latent Tuberculosis Infection

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Correlation between results of TST and IGRA tests and exposure scores [ Time Frame: 2 months after exposure ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	295
Study Start Date:	October 2004
Study Completion Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All subjects screened after exposure to a case of active and contagious tuberculosis in the Geneva area

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557765

Locations

Switzerland
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

More Information

No publications provided

Study ID Numbers:	04-184
Study First Received:	November 13, 2007
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00557765
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:

Tuberculosis
Latent tuberculosis infection
Interferon gamma release assay
Contact tracing

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Interferon Type II
Interferons

Mycobacterium Infections
Tuberculosis
Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Communicable Diseases
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on February 12, 2009