Design of an Integrative Algorithm for Staging Tuberculosis (STAGE-TB)

December 22, 2024 updated by: Fundació Institut Germans Trias i Pujol

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

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.

Study Overview

Status

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
          • Neus Jové, MD
        • Principal Investigator:
          • Neus Jové, MD
        • Sub-Investigator:
          • Francisca Sánchez, MD
        • Sub-Investigator:
          • Marisol Domínguez, MD
        • Sub-Investigator:
          • Núria López, MD
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Drassanes
        • Contact:
          • Adrián Sánchez, MD, PhD
        • Principal Investigator:
          • Adrián Sánchez, MD, PhD
        • Sub-Investigator:
          • Malú De Souza, MD, PhD
        • Sub-Investigator:
          • Jiménez, MD
        • Principal Investigator:
          • Pere Soler, MD, PhD
        • Sub-Investigator:
          • Andrea Martín, MD
        • Sub-Investigator:
          • Antoni Soriano, MD, PhD
        • Sub-Investigator:
          • Teresa Tórtola, MD, PhD
        • Sub-Investigator:
          • Israel Molina, MD, PhD
        • Sub-Investigator:
          • Núria Saborit
      • Barcelona, Spain
        • Recruiting
        • Servicios Clínicos de Barcelona
        • Contact:
          • Joan Pau Millet
        • Principal Investigator:
          • Joan Pau Millet, MD, PhD
        • Sub-Investigator:
          • Xavier Casas, MD
        • Sub-Investigator:
          • Israel Molina, MD
        • Sub-Investigator:
          • Gónzalez-Díaz, MD
        • Sub-Investigator:
          • Maldonado, MD
        • Sub-Investigator:
          • Altet, MD
        • Sub-Investigator:
          • Jaume Ollé-Goig, MD
        • Sub-Investigator:
          • Núria Forcades, MD
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:
          • Zoran Stojanovic, MD, PhD
        • Sub-Investigator:
          • Cristina Prat, MD, PhD
        • Principal Investigator:
          • Zoran Stojanovic, MD, PhD
      • Esplugues De Llobregat, Barcelona, Spain, 08950
        • Recruiting
        • Hospital Sant Joan De Deu
        • Contact:
          • Antoni Noguera, MD, PhD
        • Principal Investigator:
          • Antoni Noguera, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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, Hospital del Mar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical changes
Time Frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Changes in clinical status
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Microbiological changes
Time Frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
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
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)
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
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.
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
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.
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
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.
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
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).
timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

Germans Trias i Pujol Hospital
Hospital del Mar
Hospital Sant Joan de Deu
Hospital Universitari Vall d'Hebron (Drassanes)
Servicios Clínicos de Barcelona

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 3, 2017

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 22, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAGE-TB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD that underlie results in a publication might be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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