TuberculosisSYS-TB-SNCT06706596
A Systemic Screening for TB Disease in High-risk Groups in Barcelona
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
Trial summary
The purpose of this screening study is to identify and screen vulnerable population in Barcelona for active pulmonary tuberculosis Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary
- What is being tested?
- Screening for TB symptoms and Chest X-ray
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jul 2022to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals from populations identified as high-risk for tuberculosis in the Barcelona metropolitan area
Who may be able to join
- -Belonging to a population at high risk for tuberculosis (TB)
Who cannot join
- -Not belonging to a population at high risk for tuberculosis (TB)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
IGTP
Badalona, 08916
Cristina Vilaplana, MD, PhD, cvilaplana@igtp.cat
Nino Gogichadze, MD, MsC, ngogichadze@igtp.cat
About this study
Official title: Implementing a Systemic Screening for TB Disease in High-risk Groups in Barcelona Area
The purpose of this screening study is to identify and screen vulnerable population in Barcelona for active pulmonary tuberculosis
Read the detailed description
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)
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary
- Being tested
- Screening for TB symptoms, Chest X-ray
- Keywords
- Tuberculosis, Tuberculosis infection, Tuberculosis screening, Vulnerable populations, Refugees, Migrants, Pulmonary tuberculosis
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for TB symptomsOther
Individuals will be screened for cough, blood in sputum, fever, weight loss, night sweats and chills lasting for >2 weeks
Chest X-rayDiagnostic test
Chest X-ray will be performed to diagnose or exclude TB
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Screening for TB symptoms; Diagnostic Test: Chest X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1 month
Secondary outcomes (2)
Cost-effectiveness analysis
Cost-effectiveness analysis of the TB screening
Measured: 1 day
Time spent during screening
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start22 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Public Health Agency, Consorci Sanitari de Barcelona (CSB), SMA-TB Consortium, INNOVA4TB Consortium, Fundació Lluita contra les Infeccions, Hospital Vall d'Hebron -Unitat de Drassanes, ADVANCE-TB Consortium, Germans Trias i Pujol Hospital
- Responsible party
- Principal investigator, Cris Vilaplana, Fundació Institut Germans Trias i Pujol
- Investigators
- Cristina Vilaplana, MD, PhD, Study chair, Fundació i Hospital Germans Trias i Pujol (IGTP-HUGTIP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706596
- Sponsor's protocol ID
- SYS-TB-S
- Acronym
- SYS-TB-S
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Systemic Screening for TB Disease in High-risk Groups in Barcelona Area
- ClinicalTrials.gov ID
- NCT06706596
- Acronym / sponsor ID
- SYS-TB-S / SYS-TB-S
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary
- Keywords
- Tuberculosis, Tuberculosis infection, Tuberculosis screening, Vulnerable populations, Refugees, Migrants, Pulmonary tuberculosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Catalan Public Health Agency, Consorci Sanitari de Barcelona (CSB), SMA-TB Consortium, INNOVA4TB Consortium, Fundació Lluita contra les Infeccions, Hospital Vall d'Hebron -Unitat de Drassanes, ADVANCE-TB Consortium, Germans Trias i Pujol Hospital
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (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.
The purpose of this screening study is to identify and screen vulnerable population in Barcelona for active pulmonary tuberculosis
Detailed description
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)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vulnerable populations residing in the Barcelona metropolitan area with a high risk of developing TB | – | Other: Screening for TB symptoms, Diagnostic Test: Chest X-rayIndividuals 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals from populations identified as high-risk for tuberculosis in the Barcelona metropolitan area
Key inclusion criteria (1 listed)
- -Belonging to a population at high risk for tuberculosis (TB)
Key exclusion criteria (1 listed)
- -Not belonging to a population at high risk for tuberculosis (TB)
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 |
|---|---|---|
| Screening for TB symptomsIndividuals will be screened for cough, blood in sputum, fever, weight loss, night sweats and chills lasting for >2 weeks | Other | Vulnerable populations residing in the Barcelona metropolitan area with a high risk of developing TB |
| Chest X-rayChest X-ray will be performed to diagnose or exclude TB | Diagnostic test | Vulnerable populations residing in the Barcelona metropolitan area with a high risk of developing TB |
Primary outcome
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)
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
2 secondary outcomes
Cost-effectiveness analysis
Time frame: 1 day
Time spent during screening
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Cristina Vilaplana, MD, PhD study chair
Fundació i Hospital Germans Trias i Pujol (IGTP-HUGTIP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by Fundació Institut Germans Trias i Pujol 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Vilaplana, MD, PhD (+34930330527, cvilaplana@igtp.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals who screen positive for pulmonary TB symptoms (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.