Tuberculosis In Children Visiting Friends and Relatives

July 17, 2020 updated by: Hospital Mutua de Terrassa

Tuberculosis Infection in Children Visiting Friends and Relatives in Countries With High Incidence of Tuberculosis: a Study Protocol

In countries with a low incidence of Tuberculosis (TB), the incidence remains higher among the immigrant population than among the autochthonous population beyond the first years after arrival in the host country. In addition, at a pediatric level, most cases are produced in immigrant children and the children of immigrants. This persistence of a greater incidence in the immigrant population might, in part, be explained by the increase in exposure to Mycobacterium tuberculosis during trips to their country of origin to visit friends and relatives (VFRs). The objectives of the study are to estimate the risk of latent infection by M. tuberculosis (LTBI)/TB in children VFRs and the factors associated with this risk. The investigators will also study the behavior of the diagnostic tests. This project will be carried out in collaboration with 21 primary health care centers and 5 hospitals in Catalonia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A prospective study will be carried out. The study subjects are children under 15 years of age, which are children of immigrants and born or not in Spain, who travel to VFRs to countries with an elevated incidence of TB (> 40 cases/100,000 inhabitants). A sample size of 492 children was estimated. Children will be recruited during a programmed visit to a traveler health clinic or a primary care center, a questionnaire will be completed with sociodemographic, epidemiologic and clinical data and a tuberculin skin test (TST) will be performed and read at 48-72 hours. At 8-12 weeks after returning from the travel abroad the child will have a new visit in which a questionnaire will be completed with epidemiological and clinical data, an a TST and QFT-Plus test will be performed. The rate of incidence of LTBI will be estimated per individual/month and person/year per country visited and by age group.

Study Type

Interventional

Enrollment (Anticipated)

492

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 Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Universitari Mutua Terrassa

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

6 months to 14 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria (all criteria must be met):

  • Informed consent must be obtained from the parents of legal guardian.
  • Less than 15 years of age.
  • One or both of the parents is from a country with an elevated incidence of TB. A country is considered to have an elevated incidence of TB when this incidence is 3-fold higher than the incidence in Catalunya, that is approximately 40/100,000 inhabitants. Countries with official reports describing an incidence less than the value proposed but which have regions with > 40 cases /100,000 inhabitants are also included (Table and figure 1)
  • The journey to the country of origin is made by at least one of the parents.
  • The duration of the visit to the country of origin is of at least 21 days.

Exclusion Criteria:

  • Previous TB or LTBI.
  • Tourist visit to hotels and resorts with scarce contact with the autochthonous population.
  • Primary or secondary immunodeficiency to treatment with corticosteroids, transplantation, treatment with anti-tumor necrosis factor, chronic renal insufficiency.
  • Congenital cardiopathy.
  • Cystic fibrosis of the pancreas and other congenital diseases of pulmonary origin.

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: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TB infection-screening benefiting group
children VFRs under 15 years of age (which are children of immigrants and born or not in Spain) who travel to countries with an elevated incidence of TB will be screened for LTBI after their return.
Other: TB infection-screening benefiting group
The children who participate in the study will be recruited during a programmed visit to a traveler health clinic or a primary care center. During the first visit the parents or legal guardian will be interviewed, a questionnaire will be completed with sociodemographic, epidemiologic and clinical data and a tuberculin skin test (TST) will be performed and read at 48-72 hours. At 8-12 weeks after returning from the travel abroad the child will have a new visit. A new interview will be carried out with the parents or legal guardian and a questionnaire will be completed with epidemiological and clinical data. The child will undergo a new TST and QFT-Plus test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in health status: LTBI diagnosis after having traveled abroad
Time Frame: At 8-12 weeks after returning from the travel abroad
To be evaluated with Tuberculin test and Interferon-gamma release assay (QuantiFERON-TB Gold Plus (QFT-Plus)). LTBI is defined as having at least one positive infection test (Tuberculin Test and/or QFT-Plus)
At 8-12 weeks after returning from the travel abroad

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic characteristics of the patients
Time Frame: baseline (before traveling abroad)

sex, date of birth, country of child's birth, country of father's and mother's birth.

To be evaluated with an ad hoc questionnaire.
baseline (before traveling abroad)
Epidemiological data (before travel abroad):
Time Frame: baseline (before travel abroad)

history of previous study for tuberculosis infection, pre-travel visit date, country of trip, probable travel date.

To be evaluated with an ad hoc questionnaire.
baseline (before travel abroad)
Epidemiological data (after travel abroad):
Time Frame: At 8-12 weeks after returning from the travel abroad

travel date, post-travel visit date, return date of the trip, travel time, number of cohabitants at the address visited, travel environment (rural / urban / mixed), smokers in the home visited.

To be evaluated with an ad hoc questionnaire.
At 8-12 weeks after returning from the travel abroad
Clinical data: Bacillus Calmette-Guerin (BCG) vaccination
Time Frame: baseline (before travel abroad)
Bacillus Calmette-Guerin (BCG) vaccination (yes/no type). To be evaluated with an ad hoc questionnaire.
baseline (before travel abroad)
Clinical data: presence of BCG scar
Time Frame: baseline (before travel abroad)
presence of BCG scar (yes/no type). To be evaluated with an ad hoc questionnaire.
baseline (before travel abroad)
Clinical data: height
Time Frame: baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )
height in meters. To be evaluated with an ad hoc questionnaire.
baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )
Clinical data: weight
Time Frame: baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )
weight in kilograms. To be evaluated with an ad hoc questionnaire. To be evaluated with an ad hoc questionnaire.
baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )

Collaborators and Investigators

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

Sponsor

Hospital Mutua de Terrassa

Collaborators

Institut Català de la Salut
Hospital Vall d'Hebron
Public Health Agency of Barcelona
Hospital Universitari Sant Joan de Reus
Hospital Sant Joan de Deu
Hospital de Tortosa Verge de la Cinta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 20, 2020

First Posted (ACTUAL)

January 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16/094

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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