Use of a Gamma-IFN Assay in Contact Tracing for Tuberculosis in a Low-Incidence, High Immigration Area
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| First Received Date ICMJE | November 13, 2007 | ||||
| Last Updated Date | November 13, 2007 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Correlation between results of TST and IGRA tests and exposure scores [ Time Frame: 2 months after exposure ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of a Gamma-IFN Assay in Contact Tracing for Tuberculosis in a Low-Incidence, High Immigration Area | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All subjects screened after exposure to a case of active and contagious tuberculosis in the Geneva area |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 295 | ||||
| Completion Date | January 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00557765 | ||||
| Other Study ID Numbers ICMJE | 04-184 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Hospital, Geneva | ||||
| Collaborators ICMJE | Ligue Pulmonaire Genevoise | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Geneva | ||||
| Verification Date | November 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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