Design of an Integrative Algorithm for Staging Tuberculosis
ConditionTuberculosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFundació Institut Germans Trias i Pujol
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Not consenting to data/samples donation
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: TB patients
Trial outcomes
Primary outcomes
1
Clinical changes
Changes in clinical status
Time frame
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)2
Microbiological changes
Changes in microbiological cultures
Time frame
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)Secondary outcomes
1
Changes in Biomarkers values
Changes in the biomarkers along time assessed by using analyzing parameters in blood and urine samples (by ELISA and LUMINEX)
Time frame
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)2
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.
Time frame
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)3
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.
Time frame
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)4
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.
Time frame
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Institut Germans Trias i Pujol
Lead sponsor
Hospital Universitari Vall d'Hebron (Drassanes)
Collaborator
Servicios Clínicos de Barcelona
Collaborator
Germans Trias i Pujol Hospital
Collaborator
Hospital Sant Joan de Deu
Collaborator
Hospital del Mar
Collaborator
Source ClinicalTrials.gov