Clinical trial NCT03691883: Design of an Integrative Algorithm for Staging Tuberculosis
Official title: Design of an Integrative Algorithm for Staging Tuberculosis to Improve Clinical Management.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Keywords: tuberculosis, infectious diseases
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Vall d'Hebron (Drassanes)
name: Servicios Clínicos de Barcelona
name: Germans Trias i Pujol Hospital
name: Hospital Sant Joan de Deu
name: Hospital del Mar
First posted: 2018-10-02
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Clinical changes
timeFrame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
measure: Microbiological changes
timeFrame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Secondary outcomes:
measure: Changes in Biomarkers values
timeFrame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
measure: Radiological Score Value
timeFrame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
measure: Changes in SGRQ score
timeFrame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
measure: Changes in Kessler-10 score
timeFrame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
measure: Changes in Health Quality of Life measures along time using BCN-Q questionnaire
timeFrame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Esplugues De Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Drassanes
city: Barcelona
country: Spain
facility: Servicios Clínicos de Barcelona
Study officials:
affiliation: Fundació Institut Germans Trias i Pujol
name: Cris Vilaplana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.