Tuberculosis
Conditions
Keywords
tuberculosis, infectious diseases
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.
Interventions
None listed
Sponsors
Hospital Universitari Vall d'Hebron (Drassanes)
Servicios Clínicos de Barcelona
Germans Trias i Pujol Hospital
Hospital Sant Joan de Deu
Hospital del Mar
Fundació Institut Germans Trias i Pujol
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical changes | timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) | Changes in clinical status |
| Microbiological changes | timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) | Changes in microbiological cultures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in SGRQ 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 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. |
| Changes in Biomarkers values | timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) | Changes in the biomarkers along time assessed by using analyzing parameters in blood and urine samples (by ELISA and LUMINEX) |
| 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) | Changes in Health Quality of Life measures along time using BCN-Q questionnaire (descriptive questionnaire). |
| 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 assessed by using the questionnaire Kessler-10 (K10, numeric score). Higher values represent a worse outcome. |
| Radiological Score Value | timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) | 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. |
Countries
Spain
Contacts
Primary ContactCris Vilaplana, MD, PhD
Backup ContactLaura Villegas
Outcome results
None listed