Design of an Integrative Algorithm for Staging Tuberculosis

NCT03691883 | Recruiting

• 1 other identifier: STAGE-TB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Tuberculosis

Keywords

tuberculosis, infectious diseases

Outcome Measures

Primary Outcomes (2)

• Clinical changes

  Changes in clinical status

  timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)

• Microbiological changes

  Changes in microbiological cultures

  timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)

Secondary Outcomes (5)

• Changes in Biomarkers values

  timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)

• Radiological Score Value

  timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)

• Changes in SGRQ score

  timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)

• Changes in Kessler-10 score

  timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)

• Changes in Health Quality of Life measures along time using BCN-Q questionnaire

  timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TB patients which clinical management is done at the following clinical centers: Servicios Clínicos, Hospital Universitari Vall d'Hebron-Drassanes or Hospital Universitari Germans Trias i Pujol.

You may qualify if:

• 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.

You may not qualify if:

• Not consenting to data/samples donation

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• Hospital Universitari Vall d'Hebron (Drassanes): collaborator
• Servicios Clínicos de Barcelona: collaborator
• Germans Trias i Pujol Hospital: collaborator
• Hospital Sant Joan de Deu: collaborator
• Hospital del Mar: collaborator

Study Sites (5)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Universitari Vall d'Hebron-Drassanes

Barcelona, Spain

RECRUITING

Servicios Clínicos de Barcelona

Barcelona, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 38349459 BACKGROUND

• 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.

  PMID: 37275492 BACKGROUND

• 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.

  PMID: 31850353 RESULT

Related Links

• Institutional webpage- Experimental TB Unit

Biospecimen

Retention: SAMPLES WITH DNA

Bloood samples for determination of DNA

MeSH Terms

Conditions

Tuberculosis; Communicable Diseases

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cris Vilaplana, MD, PhD

  Fundació Institut Germans Trias i Pujol

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cris Vilaplana, MD, PhD

CONTACT

934978677; cvilaplana@gmail.com

Laura Villegas

CONTACT

+34934978681; secretary.ute@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2017
• First Posted: October 2, 2018
• Study Start: April 19, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

ES (5)