A Systemic Screening for TB Disease in High-risk Groups in Barcelona

NCT ID: NCT06706596

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-22

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this screening study is to identify and screen vulnerable population in Barcelona for active pulmonary tuberculosis

Detailed Description

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If eligible and verbal consent is obtained, individuals:

1. Will attend a small talk/lecture about Tuberculosis (TB) disease
2. Will be interviewed and screened for the presence of TB symptoms: cough, blood in sputum, fever, weight loss, night sweats and chills lasting for \>2 weeks
3. Individuals screened positive for TB will be referred to the hospital for further testing (Chest X-ray, visit, lab tests)

Conditions

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Tuberculosis Tuberculosis, Pulmonary

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Vulnerable populations residing in the Barcelona metropolitan area with a high risk of developing TB

Individuals from vulnerable populations residing in the Barcelona metropolitan area who are at high risk of developing tuberculosis (i.e. war refugees, migrants, individuals living in socio-deprived neighborhoods)

Screening for TB symptoms

Intervention Type OTHER

Individuals will be screened for cough, blood in sputum, fever, weight loss, night sweats and chills lasting for \>2 weeks

Chest X-ray

Intervention Type DIAGNOSTIC_TEST

Chest X-ray will be performed to diagnose or exclude TB

Interventions

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Screening for TB symptoms

Individuals will be screened for cough, blood in sputum, fever, weight loss, night sweats and chills lasting for \>2 weeks

Intervention Type OTHER

Chest X-ray

Chest X-ray will be performed to diagnose or exclude TB

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

-Belonging to a population at high risk for tuberculosis (TB)

Exclusion Criteria

-Not belonging to a population at high risk for tuberculosis (TB)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Catalan Public Health Agency

UNKNOWN

Sponsor Role collaborator

Consorci Sanitari de Barcelona (CSB)

UNKNOWN

Sponsor Role collaborator

SMA-TB Consortium

UNKNOWN

Sponsor Role collaborator

INNOVA4TB Consortium

UNKNOWN

Sponsor Role collaborator

Fundació Lluita contra les Infeccions

UNKNOWN

Sponsor Role collaborator

Hospital Vall d'Hebron -Unitat de Drassanes

UNKNOWN

Sponsor Role collaborator

ADVANCE-TB Consortium

UNKNOWN

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role lead

Responsible Party

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Cris Vilaplana

Head of Tuberculosis Investigational Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristina Vilaplana, MD, PhD

Role: STUDY_CHAIR

Fundació i Hospital Germans Trias i Pujol (IGTP-HUGTIP)

Locations

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IGTP

Badalona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Cristina Vilaplana, MD, PhD

Role: CONTACT

+34930330527

Nino Gogichadze, MD, MsC

Role: CONTACT

+34661079125

Facility Contacts

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Cristina Vilaplana, MD, PhD

Role: primary

Nino Gogichadze, MD, MsC

Role: backup

Other Identifiers

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SYS-TB-S

Identifier Type: -

Identifier Source: org_study_id