Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
Primary Purpose
Latent Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Latent Tuberculosis focused on measuring latent tuberculosis, tuberculin skin test, Interferon gamma release assay, immigration
Eligibility Criteria
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
Sites / Locations
- Sheba Medical Center
- Israeli Defense Forces
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Second generation immigrants from high TB incidence countries
Native Israelis
Arm Description
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA).
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA).
Outcomes
Primary Outcome Measures
Interferon gamma release assay ( IGRA)
Secondary Outcome Measures
Full Information
NCT ID
NCT02073669
First Posted
February 25, 2014
Last Updated
January 24, 2019
Sponsor
Sheba Medical Center
Collaborators
Tel Aviv Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT02073669
Brief Title
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
Official Title
Better Identification of Latent Tuberculosis Infection Among Israeli Young Adults by Comparison Skin Tests and Interferon Gamma Releasing Assays (IGRA)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
Tel Aviv Lung Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
latent tuberculosis, tuberculin skin test, Interferon gamma release assay, immigration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Second generation immigrants from high TB incidence countries
Arm Type
Other
Arm Description
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA).
Arm Title
Native Israelis
Arm Type
Other
Arm Description
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA).
Intervention Type
Procedure
Intervention Name(s)
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)
Primary Outcome Measure Information:
Title
Interferon gamma release assay ( IGRA)
Time Frame
Up to 3 months after tuberculin skin test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Israeli Defense Forces
City
Ramat-Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
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