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NCT02073669 Clinical Trial

Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults

Latent Tuberculosis Clinical Trial

Official title:
Better Identification of Latent Tuberculosis Infection Among Israeli Young Adults by Comparison Skin Tests and Interferon Gamma Releasing Assays (IGRA)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02073669
Other study ID # SHEBA-13-0668-DS-CTIL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date November 2018

Study information
Verified date January 2019
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group.

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date November 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Age 18-25

- Men and women

- Second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000).

- Native Israelis without a family member who was born in a country with high incidence of tuberculosis.

Exclusion Criteria:

- Prior contact with a tuberculosis patient

- Working (more than a month) in high risk setting such as health care workers, working with immigrants from countries with high incidence of tuberculosis.

- HIV infection and any immunodeficiency condition.

- Recent live-virus vaccination

- Acute infectious disease

- Prior serious reaction to tuberculin skin test

- Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan
Israel Israeli Defense Forces Ramat-Gan

Sponsors (2)
Lead Sponsor Collaborator
Sheba Medical Center Tel Aviv Lung Association

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Interferon gamma release assay ( IGRA) Up to 3 months after tuberculin skin test
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