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

January 24, 2019 updated by: Sheba Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Ramat-Gan, Israel
        • Israeli Defense Forces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Second generation immigrants from high TB incidence countries
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA).
Procedure: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)
Other: Native Israelis
Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA).
Procedure: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interferon gamma release assay ( IGRA)
Time Frame: Up to 3 months after tuberculin skin test
Up to 3 months after tuberculin skin test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Tel Aviv Lung Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-13-0668-DS-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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