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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Institut Germans Trias i Pujol

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Germans Trias i Pujol Hospital
Hospital del Mar
Hospital Sant Joan de Deu
Hospital Universitari Vall d'Hebron (Drassanes)
Servicios Clínicos de Barcelona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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