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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00557765
Other study ID # 04-184
Secondary ID
Status Completed
Phase N/A
First received November 13, 2007
Last updated November 13, 2007
Start date October 2004
Est. completion date January 2006

Study information

Verified date November 2007
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 295
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Switzerland Centre antituberculeux; Geneva University Hospital Geneva

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Geneva Ligue Pulmonaire Genevoise

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between results of TST and IGRA tests and exposure scores 2 months after exposure
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