NCT02073669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

4.4 years

First QC Date

February 25, 2014

Last Update Submit

January 24, 2019

Conditions

Latent Tuberculosis

Keywords

latent tuberculosistuberculin skin testInterferon gamma release assayimmigration

Outcome Measures

Primary Outcomes (1)

  • Interferon gamma release assay ( IGRA)

    Up to 3 months after tuberculin skin test

Study Arms (2)

Second generation immigrants from high TB incidence countries

OTHER

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)

Native Israelis

OTHER

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)

Interventions

Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)PROCEDURE
Native IsraelisSecond generation immigrants from high TB incidence countries

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Israeli Defense Forces

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Blood Specimen CollectionInterferon-gamma Release Tests

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesImmunologic TestsImmunologic Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 27, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

IL(2)