NCT04236765

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 492 (estimated)
• Sponsor: Hospital Mutua de Terrassa · Academic / Other
• Sex: All
• Age: 6 Months – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-01-22
• Last updated: 2020-07-20

Locations

1 site across 1 country: Spain