Tuberculosis In Children Visiting Friends and Relatives
Tuberculosis Infection in Children Visiting Friends and Relatives in Countries With High Incidence of Tuberculosis: a Study Protocol
1 other identifier
interventional
492
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 20, 2020
July 1, 2020
3 years
January 10, 2020
July 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
At 8-12 weeks after returning from the travel abroad
Secondary Outcomes (7)
Sociodemographic characteristics of the patients
baseline (before traveling abroad)
Epidemiological data (before travel abroad):
baseline (before travel abroad)
Epidemiological data (after travel abroad):
At 8-12 weeks after returning from the travel abroad
Clinical data: Bacillus Calmette-Guerin (BCG) vaccination
baseline (before travel abroad)
Clinical data: presence of BCG scar
baseline (before travel abroad)
- +2 more secondary outcomes
Study Arms (1)
TB infection-screening benefiting group
EXPERIMENTALchildren 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Mutua de Terrassalead
- Public Health Agency of Barcelonacollaborator
- Hospital Vall d'Hebroncollaborator
- Hospital Sant Joan de Deucollaborator
- Institut Català de la Salutcollaborator
- Hospital Universitari Sant Joan de Reuscollaborator
- Hospital de Tortosa Verge de la Cintacollaborator
Study Sites (1)
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Related Publications (1)
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.
PMID: 32899054DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2020
First Posted
January 22, 2020
Study Start
January 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
July 20, 2020
Record last verified: 2020-07