Design of an Integrative Algorithm for Staging Tuberculosis

NCT ID: NCT03691883

Last Updated: 2024-12-27

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-19

Study Completion Date

2026-12-31

Brief Summary

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Tuberculosis is a chronic infectious disease that affects 10 million people, 300 in the city of Barcelona, every year. With serious consequences at public health level, it is associated with other diseases, and generated and influenced by many social and psychological factors. This study aims to stage tuberculosis disease by an integrative approach.

Detailed Description

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Tuberculosis is a chronic infectious disease that affects 10 million people, there are 300 new cases 300 in the city of Barcelona, every year. Tuberculosis has serious consequences at public health level. It is associated with other diseases, and generated and influenced by many social and psychological factors. This study aims to stage tuberculosis disease by a novel integrative approach.

Conditions

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Tuberculosis

Keywords

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tuberculosis, infectious diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TB patients

TB patients diagnosed and followed-up in Barcelona, at the following Hospitals/Clinics: Servicios Clínicos, Hospital Universitari Germans Trias i Pujol, Hospital Universitari Vall d'Hebron-Drassanes, Hospital del Mar.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* TB diagnosis (all forms), microbiologically confirmed (by AFB+, GenXpert+ or Culture+)
* Clinical management of the patients being done at Servicios Clínicos, Hospital Universitari Vall d'Hebron-Drassanes or Hospital Universitari Germans Trias i Pujol.

Exclusion Criteria

* Not consenting to data/samples donation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role lead

Hospital Universitari Vall d'Hebron (Drassanes)

UNKNOWN

Sponsor Role collaborator

Servicios Clínicos de Barcelona

UNKNOWN

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cris Vilaplana, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut Germans Trias i Pujol

Locations

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Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron-Drassanes

Barcelona, , Spain

Site Status RECRUITING

Servicios Clínicos de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Cris Vilaplana, MD, PhD

Role: CONTACT

Phone: 934978677

Email: [email protected]

Laura Villegas

Role: CONTACT

Phone: +34934978681

Email: [email protected]

Facility Contacts

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Zoran Stojanovic, MD, PhD

Role: primary

Antoni Noguera, MD, PhD

Role: primary

Neus Jové, MD

Role: primary

Adrián Sánchez, MD, PhD

Role: primary

Joan Pau Millet

Role: primary

References

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Romero-Tamarit A, Valles X, Munar-Garcia M, Espinosa-Pereiro J, Saborit N, Tortola MT, Stojanovic Z, Roure S, Antuori A, Cardona PJ, Soriano-Arandes A, Martin-Nalda A, Espiau M, de Souza-Galvao ML, Jimenez MA, Noguera-Julian A, Molina I, Casas X, Dominguez-Alvarez M, Jove N, Gogichadze N, L Fonseca K, Arias L, Millet JP, Sanchez-Montalva A, Vilaplana C. A longitudinal prospective study of active tuberculosis in a Western Europe setting: insights and findings. Infection. 2024 Apr;52(2):611-623. doi: 10.1007/s15010-024-02184-2. Epub 2024 Feb 13.

Reference Type BACKGROUND
PMID: 38349459 (View on PubMed)

Roure S, Valles X, Sopena N, Benitez RM, Reynaga EA, Bracke C, Loste C, Mateu L, Antuori A, Baena T, Portela G, Llussa J, Flamarich C, Soldevila L, Tenesa M, Perez R, Plasencia E, Bechini J, Pedro-Botet ML, Clotet B, Vilaplana C. Disseminated tuberculosis and diagnosis delay during the COVID-19 era in a Western European country: a case series analysis. Front Public Health. 2023 May 18;11:1175482. doi: 10.3389/fpubh.2023.1175482. eCollection 2023.

Reference Type BACKGROUND
PMID: 37275492 (View on PubMed)

Pujol-Cruells A, Vilaplana C. Specific Interventions for Implementing a Patient-Centered Approach to TB Care in Low-Incidence Cities. Front Med (Lausanne). 2019 Nov 26;6:273. doi: 10.3389/fmed.2019.00273. eCollection 2019.

Reference Type RESULT
PMID: 31850353 (View on PubMed)

Related Links

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Other Identifiers

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STAGE-TB

Identifier Type: -

Identifier Source: org_study_id