Design of an Integrative Algorithm for Staging Tuberculosis

Study Overview
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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.

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

Conditions
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Tuberculosis

Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TB patients<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Biomarkers values | Changes in the biomarkers along time assessed by using analyzing parameters in blood and urine samples (by ELISA and LUMINEX) | timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) | 
| Radiological Score Value | Changes in the BCN-SA Radiological Score Value. This Score assesses the sum of acute and chronic findings in the chest X-ray. Per each finding, a maximum score of 8 is recorded. The total score value is calculated by adding all the individual findings score values. Higher values of total score represent a worse outcome. | timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) | 
| Changes in SGRQ score | Changes in Health Quality of Life measures along time assessed by using the Saint George's Respiratory Questionnaire (SGRQ, numeric score). It measures 3 subscales (symptoms/activity/impacts) and The Total score is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the total weight for the questionnaire. Higher values represent a worse outcome. | timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) | 
| Changes in Kessler-10 score | Changes in Health Quality of Life measures along time assessed by using the questionnaire Kessler-10 (K10, numeric score). Higher values represent a worse outcome. | 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 | Changes in Health Quality of Life measures along time using BCN-Q questionnaire (descriptive questionnaire). | timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tuberculosis, infectious diseases