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

NCT06706596 | Recruiting

• 1 other identifier: SYS-TB-S
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tuberculosis; Tuberculosis, Pulmonary

Keywords

Tuberculosis; Tuberculosis infection; Tuberculosis screening; Vulnerable populations; Refugees; Migrants; Pulmonary tuberculosis

Outcome Measures

Primary Outcomes (2)

• Number of individuals who screen positive for pulmonary TB symptoms

  Number of individuals who screen positive for pulmonary TB symptoms (cough, blood in sputum, fever, weight loss, night sweats and chills lasting for \>2 weeks)

  1 day

• Number of individuals who are diagnosed with pulmonary TB symptoms

  Number of individuals who are diagnosed with pulmonary TB symptoms after referral to the hospital

  1 month

Secondary Outcomes (2)

• Cost-effectiveness analysis

  1 day

• Time spent during screening

  1 day

Study Arms (1)

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)

Other: Screening for TB symptoms; Diagnostic Test: Chest X-ray

Interventions

Screening for TB symptoms OTHER

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

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

Chest X-ray DIAGNOSTIC_TEST

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals from populations identified as high-risk for tuberculosis in the Barcelona metropolitan area

You may qualify if:

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

You may not qualify if:

• Not belonging to a population at high risk for tuberculosis (TB)

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• Catalan Public Health Agency: collaborator
• Consorci Sanitari de Barcelona (CSB): collaborator
• SMA-TB Consortium: collaborator
• INNOVA4TB Consortium: collaborator
• Fundació Lluita contra les Infeccions: collaborator
• Hospital Vall d'Hebron -Unitat de Drassanes: collaborator
• ADVANCE-TB Consortium: collaborator
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

IGTP

Badalona, 08916, Spain

RECRUITING

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary; Latent Tuberculosis

Interventions

Mass Screening; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Latent Infection

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Cristina Vilaplana, MD, PhD

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

  STUDY CHAIR

Central Study Contacts

Cristina Vilaplana, MD, PhD

CONTACT

+34930330527; cvilaplana@igtp.cat

Nino Gogichadze, MD, MsC

CONTACT

+34661079125; ngogichadze@igtp.cat

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Tuberculosis Investigational Unit

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: July 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)