Tuberculosis InfectionNCT04236765
Tuberculosis In Children Visiting Friends and Relatives
A study testing TB infection-screening benefiting group in people with Tuberculosis Infection, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis Infection
- What is being tested?
- TB infection-screening benefiting group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221
Pilar Arcusa, parcusa@mutuaterrassa.es
About this study
Official title: Tuberculosis Infection in Children Visiting Friends and Relatives in Countries With High Incidence of Tuberculosis: a Study Protocol
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.
Read the 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
- Being tested
- TB infection-screening benefiting group
- Keywords
- Tuberculosis, Latent Tuberculosis, Children, Immigrant, Incidence, Travel-Related Infection, Tuberculin Test, Interferon-gamma Release Assay
- Medical subject headings
- Latent Tuberculosis, Tuberculosis, Travel-Related Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB infection-screening benefiting groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TB infection-screening benefiting group | Experimental | 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. Receives: Other: TB infection-screening benefiting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 8-12 weeks after returning from the travel abroad
Secondary outcomes (7)
Sociodemographic characteristics of the patients
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.
Measured: baseline (before traveling abroad)
Epidemiological data (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.
Measured: baseline (before travel abroad)
Epidemiological data (after 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.
Measured: At 8-12 weeks after returning from the travel abroad
Clinical data: Bacillus Calmette-Guerin (BCG) vaccination
Bacillus Calmette-Guerin (BCG) vaccination (yes/no type). To be evaluated with an ad hoc questionnaire.
Measured: baseline (before travel abroad)
Clinical data: presence of BCG scar
presence of BCG scar (yes/no type). To be evaluated with an ad hoc questionnaire.
Measured: baseline (before travel abroad)
Clinical data: height
height in meters. To be evaluated with an ad hoc questionnaire.
Measured: baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )
Clinical data: weight
weight in kilograms. To be evaluated with an ad hoc questionnaire. To be evaluated with an ad hoc questionnaire.
Measured: baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236765
- Sponsor's protocol ID
- P16/094
- Status last verified
- Jul 2020
- First submitted
- 10 Jan 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32899054
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberculosis Infection in Children Visiting Friends and Relatives in Countries With High Incidence of Tuberculosis: a Study Protocol
- ClinicalTrials.gov ID
- NCT04236765
- Acronym / sponsor ID
- P16/094
- Conditions
- Tuberculosis Infection
- Keywords
- Tuberculosis, Latent Tuberculosis, Children, Immigrant, Incidence, Travel-Related Infection, Tuberculin Test, Interferon-gamma Release Assay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- 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
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB infection-screening benefiting group | Experimental | Other: TB infection-screening benefiting groupchildren 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. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB infection-screening benefiting groupThe 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. | Other | TB infection-screening benefiting group |
Primary outcome
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)
7 secondary outcomes
Sociodemographic characteristics of the patients
Time frame: baseline (before traveling abroad)
Epidemiological data (before travel abroad):
Time frame: baseline (before travel abroad)
Epidemiological data (after travel abroad):
Time frame: At 8-12 weeks after returning from the travel abroad
Clinical data: Bacillus Calmette-Guerin (BCG) vaccination
Time frame: baseline (before travel abroad)
Clinical data: presence of BCG scar
Time frame: baseline (before travel abroad)
Clinical data: height
Time frame: baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )
Clinical data: weight
Time frame: baseline (before travel abroad) and follow-up (At 8-12 weeks after returning from the travel abroad )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Derived from this study: PubMed 32899054Soriano-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TB infection-screening benefiting group in people with Tuberculosis Infection, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pilar Arcusa, BSc (+34 937365050 ext. 11801, parcusa@mutuaterrassa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in health status: LTBI diagnosis after having traveled abroad (time frame: At 8-12 weeks after returning from the travel abroad). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.