Tuberculosis In Children Visiting Friends and Relatives (NCT04236765) | Clinical Trial Compass
UnknownNot Applicable
Tuberculosis In Children Visiting Friends and Relatives
Spain492 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range
6 Months – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in health status: LTBI diagnosis after having traveled abroad
Timeframe: At 8-12 weeks after returning from the travel abroad