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Tuberculosis In Children Visiting Friends and Relatives

Primary Purpose

Tuberculosis Infection

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

TB infection-screening benefiting group

About this trial

This is an interventional screening trial for Tuberculosis Infection focused on measuring Tuberculosis, Latent Tuberculosis, Children, Immigrant, Incidence, Travel-Related Infection, Tuberculin Test, Interferon-gamma Release Assay

Eligibility Criteria

6 Months - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hospital Universitari Mutua TerrassaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TB infection-screening benefiting group

Arm Description

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.

Outcomes

Primary Outcome Measures

change in health status: LTBI diagnosis after having traveled 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)

Secondary Outcome Measures

Sociodemographic characteristics of the patients

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.

Epidemiological data (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.

Epidemiological data (after 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.

Clinical data: Bacillus Calmette-Guerin (BCG) vaccination

Bacillus Calmette-Guerin (BCG) vaccination (yes/no type). To be evaluated with an ad hoc questionnaire.

Clinical data: presence of BCG scar

presence of BCG scar (yes/no type). To be evaluated with an ad hoc questionnaire.

Clinical data: height

height in meters. To be evaluated with an ad hoc questionnaire.

Clinical data: weight

weight in kilograms. To be evaluated with an ad hoc questionnaire. To be evaluated with an ad hoc questionnaire.

Full Information

NCT ID

NCT04236765

First Posted

January 10, 2020

Last Updated

July 17, 2020

Sponsor

Hospital Mutua de Terrassa

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04236765

Brief Title

Tuberculosis In Children Visiting Friends and Relatives

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Mutua de Terrassa

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis Infection

Keywords

Tuberculosis, Latent Tuberculosis, Children, Immigrant, Incidence, Travel-Related Infection, Tuberculin Test, Interferon-gamma Release Assay

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

492 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TB infection-screening benefiting group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

TB infection-screening benefiting group

Intervention Description

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.

Primary Outcome Measure Information:

Title

change in health status: LTBI diagnosis after having traveled abroad

Description

Time Frame

At 8-12 weeks after returning from the travel abroad

Secondary Outcome Measure Information:

Title

Sociodemographic characteristics of the patients

Description

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.

Time Frame

baseline (before traveling abroad)

Title

Epidemiological data (before travel abroad):

Description

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.

Time Frame

baseline (before travel abroad)

Title

Epidemiological data (after travel abroad):

Description

Time Frame

At 8-12 weeks after returning from the travel abroad

Title

Clinical data: Bacillus Calmette-Guerin (BCG) vaccination

Description

Bacillus Calmette-Guerin (BCG) vaccination (yes/no type). To be evaluated with an ad hoc questionnaire.

Time Frame

baseline (before travel abroad)

Title

Clinical data: presence of BCG scar

Description

presence of BCG scar (yes/no type). To be evaluated with an ad hoc questionnaire.

Time Frame

baseline (before travel abroad)

Title

Clinical data: height

Description

height in meters. To be evaluated with an ad hoc questionnaire.

Time Frame

baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )

Title

Clinical data: weight

Description

weight in kilograms. To be evaluated with an ad hoc questionnaire. To be evaluated with an ad hoc questionnaire.

Time Frame

baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pilar Arcusa, BSc

Phone

+34 937365050

Ext

11801

parcusa@mutuaterrassa.es

First Name & Middle Initial & Last Name or Official Title & Degree

Tomàs Maria Pérez Porcuna, PhD

Phone

+34 937365050

Ext

46004

tomas.perez.porcuna@gmail.com

Facility Information:

Facility Name

Hospital Universitari Mutua Terrassa

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08221

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pilar Arcusa

parcusa@mutuaterrassa.es

12. IPD Sharing Statement

Citations:

PubMed Identifier

32899054

Citation

Soriano-Arandes A, Cayla JA, Goncalves AQ, Orcau A, Noguera-Julian A, Padilla E, Sola-Segura E, Gordillo NR, Espiau M, Garcia-Lerin MG, Rifa-Pujol MA, Jordi Gomez I Prat, Macia-Rieradevall E, Martin-Nalda A, Eril-Rius M, Santos Santiago J, Busquets-Poblet L, Martinez RM, Perez-Porcuna TM. Tuberculosis infection in children visiting friends and relatives in countries with high incidence of tuberculosis: A study protocol. Medicine (Baltimore). 2020 Sep 4;99(36):e22015. doi: 10.1097/MD.0000000000022015.

Results Reference

derived

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Tuberculosis In Children Visiting Friends and Relatives

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