ClinicalTrials.gg
RecruitingNCT06706596SYS-TB-SUpdated Nov 29, 2024

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

An observational study in Tuberculosis and Tuberculosis, Pulmonary, sponsored by Fundació Institut Germans Trias i Pujol. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2024-11-29.

Primary conditionTuberculosis, PulmonaryRegistry: TuberculosisReclassifiedWhy we changed it
Registry
Tuberculosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Tuberculosis, Pulmonary
Why
  1. The study's listed conditions name Tuberculosis, Pulmonary, a narrower term within Tuberculosis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Fundació Institut Germans Trias i Pujol · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 3 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
3,000
Sex
All
01

Study summary

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:

  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)
02

Conditions studied

  • Tuberculosis
  • Tuberculosis, Pulmonary

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Keywords

  • Tuberculosis
  • Tuberculosis infection
  • Tuberculosis screening
  • Vulnerable populations
  • Refugees
  • Migrants
  • Pulmonary tuberculosis
03

In context

Tuberculosis, Pulmonary Reclassified

319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 300 across 83 observational studies indexed under Tuberculosis, Pulmonary.

Browse Tuberculosis, Pulmonary studies →

Lead sponsor

Fundació Institut Germans Trias i Pujol is the lead sponsor of 25 studies on the registry; 9 are open to participants now.

Compared within Tuberculosis, Pulmonary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tuberculosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherScreening for TB symptoms

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

  • Diagnostic testChest X-ray

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 day

  2. 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

    Time frame: 1 month

Secondary outcomes

  1. Cost-effectiveness analysis

    Cost-effectiveness analysis of the TB screening

    Time frame: 1 day

  2. 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

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2022 (actual). Primary completion is estimated for Dec 2026, 53 months after the start.

Of 44 observational studies under Tuberculosis, Pulmonary, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's planned 53 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2024
First posted
Nov 26, 2024
StartActual
Jul 22, 2022
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Nov 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06706596
Lead sponsor
Fundació Institut Germans Trias i Pujol
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
Cris Vilaplana (Head of Tuberculosis Investigational Unit, Fundació Institut Germans Trias i Pujol) — Principal investigator
First posted
Nov 26, 2024
Start date
Jul 22, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 29, 2024

Study contacts

Cristina Vilaplana, MD, PhD
Contact
cvilaplana@igtp.cat
+34930330527
Nino Gogichadze, MD, MsC
Contact
ngogichadze@igtp.cat
+34661079125
Cristina Vilaplana, MD, PhD
study chair · Fundació i Hospital Germans Trias i Pujol (IGTP-HUGTIP)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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