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Tuberculosis Infection In Children Visiting Friends and Relatives

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ClinicalTrials.gov Identifier: NCT04236765
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
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
Information provided by (Responsible Party):
Hospital Mutua de Terrassa

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.

Condition or disease Intervention/treatment Phase
Tuberculosis Infection Other: TB infection-screening benefiting group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 492 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Tuberculosis Infection In Children Visiting Friends and Relatives in Countries With an Elevated Incidence of Tuberculosis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. Clinical data [ Time Frame: baseline (before travel abroad) and/or follow-up (At 8-12 weeks after returning from the travel abroad ) ]

    weight and size (at baseline and follow-up), Bacillus Calmette-Guerin (BCG) vaccination (yes/no type), presence of BCG scar (yes/no type).

    To be evaluated with an ad hoc questionnaire.




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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236765


Contacts
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Contact: Pilar Arcusa, BSc +34 937365050 ext 11801 parcusa@mutuaterrassa.es
Contact: Tomàs Maria Pérez Porcuna, PhD +34 937365050 ext 46004 tomas.perez.porcuna@gmail.com

Locations
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Spain
Hospital Universitari Mutua Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Contact: Pilar Arcusa       parcusa@mutuaterrassa.es   
Sponsors and Collaborators
Hospital Mutua de Terrassa
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

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Responsible Party: Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier: NCT04236765    
Other Study ID Numbers: P16/094
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Mutua de Terrassa:
Tuberculosis
Latent Tuberculosis
Children
Immigrant
Incidence
Travel-Related Infection
Tuberculin Test
Interferon-gamma Release Assay
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections