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NCT Number: NCT06706596

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

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

Recruiting

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis, Pulmonary

Sex eligibility

All sexes

Study type

Observational

Primary location

IGTP

Badalona, 08916, Spain

Location status: Recruiting

Location contact

Cristina Vilaplana, MD, PhD

CONTACT

[email protected]

Nino Gogichadze, MD, MsC

CONTACT

[email protected]

About this study

If eligible and verbal consent is obtained, individuals:

  • Will attend a small talk/lecture about Tuberculosis (TB) disease
  • 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
  • Individuals screened positive for TB will be referred to the hospital for further testing (Chest X-ray, visit, lab tests)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Chest X-Ray

Diagnostic Test

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

Primary outcomes

  1. Number of individuals who screen positive for pulmonary TB symptoms

    Time frame: 1 day

    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)

  2. Number of individuals who are diagnosed with pulmonary TB symptoms

    Time frame: 1 month

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

Secondary outcomes

  1. Cost-effectiveness analysis

    Time frame: 1 day

    Cost-effectiveness analysis of the TB screening

  2. Time spent during screening

    Time frame: 1 day

    Duration of each step of the screening will be analysed: duration of talk about TB, duration of waiting time before individual gets screened, duration of screening

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Vilaplana, MD, PhD

CONTACT

[email protected]

+34930330527

Nino Gogichadze, MD, MsC

CONTACT

[email protected]

+34661079125

Sponsors and collaborators

Lead sponsor

Fundació Institut Germans Trias i Pujol

Other

Collaborators

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

Registry information

Official study title

Implementing a Systemic Screening for TB Disease in High-risk Groups in Barcelona Area

Acronym: SYS-TB-S

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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