Tuberculosis In Children Visiting Friends and Relatives
- Conditions
- Tuberculosis Infection
- Registration Number
- NCT04236765
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 492
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method change in health status: LTBI diagnosis after having traveled abroad 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
Name Time Method Epidemiological data (after travel abroad): 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.Clinical data: weight 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.
Epidemiological data (before travel abroad): 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.Clinical data: presence of BCG scar baseline (before travel abroad) presence of BCG scar (yes/no type). To be evaluated with an ad hoc questionnaire.
Clinical data: height 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.
Sociodemographic characteristics of the patients 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.Clinical data: Bacillus Calmette-Guerin (BCG) vaccination baseline (before travel abroad) Bacillus Calmette-Guerin (BCG) vaccination (yes/no type). To be evaluated with an ad hoc questionnaire.
Trial Locations
- Locations (1)
Hospital Universitari Mutua Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital Universitari Mutua Terrassa🇪🇸Terrassa, Barcelona, SpainPilar ArcusaContactparcusa@mutuaterrassa.es