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Recruiting NCT03691883

Design of an Integrative Algorithm for Staging Tuberculosis

— Observational Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Tuberculosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Design of an Integrative Algorithm for Staging Tuberculosis to Improve Clinical Management.

Overview

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

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.

Primary outcome measures

  • Clinical changes [Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)]
  • Microbiological changes [Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)]
Secondary outcome measures (5)
  • Changes in Biomarkers values [Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)]
  • Radiological Score Value [Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)]
  • Changes in SGRQ score [Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)]
  • Changes in Kessler-10 score [Time frame: 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 [Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 5 centers
  • Hospital Universitari Germans Trias i Pujol — Badalona
  • Hospital Sant Joan de Déu — Esplugues de Llobregat
  • Hospital del Mar — Barcelona
  • Hospital Universitari Vall d'Hebron-Drassanes — Barcelona
  • Servicios Clínicos de Barcelona — Barcelona

Publications

  • 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 t PMID 38349459
  • 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. PMID 37275492
  • 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

Identifiers

NCT: NCT03691883 · STAGE-TB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗