Design of an Integrative Algorithm for Staging Tuberculosis
- Conditions
- Tuberculosis
- Registration Number
- NCT03691883
- Lead Sponsor
- Fundació Institut 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- Not consenting to data/samples donation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Microbiological changes timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) Changes in microbiological cultures
Clinical changes timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) Changes in clinical status
- Secondary Outcome Measures
Name Time Method 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)
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.
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 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.
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).
Trial Locations
- Locations (5)
Hospital Universitari Vall d'Hebron-Drassanes
🇪🇸Barcelona, Spain
Servicios Clínicos de Barcelona
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Sant Joan de Déu
🇪🇸Esplugues De Llobregat, Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain