Design of an Integrative Algorithm for Staging Tuberculosis

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 3, 2017

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

April 19, 2018

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical and microbiological changes[ Time Frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) ]

Changes in clinical status and microbiological cultures

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Changes in Biomarkers values[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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).
Anthropological description[ Time Frame: months 0 to 6 ]
Anthropological description of TB patients included in the cohort

Descriptive Information

Brief Title ^ICMJE

Design of an Integrative Algorithm for Staging Tuberculosis

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational [Patient Registry]

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational [Patient Registry]
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

: TB patients
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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

February 2020

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Fundació Institut Germans Trias i Pujol

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Cris Vilaplana, MD, PhD Fundació Institut Germans Trias i Pujol

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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