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

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ClinicalTrials.gov Identifier: NCT03691883
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
Hospital Universitari Vall d'Hebron (Drassanes)
Servicios Clínicos de Barcelona
Germans Trias i Pujol Hospital
Hospital Sant Joan de Deu
Hospital del Mar
Information provided by (Responsible Party):
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.

Condition or disease
Tuberculosis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Design of an Integrative Algorithm for Staging Tuberculosis to Improve Clinical Management.
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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.



Primary Outcome Measures :
  1. Clinical changes [ Time Frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) ]
    Changes in clinical status

  2. Microbiological changes [ Time Frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) ]
    Changes in microbiological cultures


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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).


Biospecimen Retention:   Samples With DNA
Bloood samples for determination of DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691883


Contacts
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Contact: Cris Vilaplana, MD, PhD 934978677 cvilaplana@gmail.com
Contact: Laura Villegas +34934978681 secretary.ute@gmail.com

Locations
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Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Zoran Stojanovic, MD, PhD         
Sub-Investigator: Cristina Prat, MD, PhD         
Principal Investigator: Zoran Stojanovic, MD, PhD         
Hospital Sant Joan de Déu Recruiting
Esplugues De Llobregat, Barcelona, Spain, 08950
Contact: Antoni Noguera, MD, PhD         
Principal Investigator: Antoni Noguera, MD, PhD         
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Neus Jové, MD         
Principal Investigator: Neus Jové, MD         
Sub-Investigator: Francisca Sánchez, MD         
Sub-Investigator: Marisol Domínguez, MD         
Sub-Investigator: Núria López, MD         
Hospital Universitari Vall d'Hebron-Drassanes Recruiting
Barcelona, Spain
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         
Servicios Clínicos de Barcelona Recruiting
Barcelona, Spain
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         
Sponsors and Collaborators
Fundació Institut Germans Trias i Pujol
Hospital Universitari Vall d'Hebron (Drassanes)
Servicios Clínicos de Barcelona
Germans Trias i Pujol Hospital
Hospital Sant Joan de Deu
Hospital del Mar
Investigators
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Principal Investigator: Cris Vilaplana, MD, PhD Fundació Institut Germans Trias i Pujol

Additional Information:
Publications of Results:
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Responsible Party: Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT03691883    
Other Study ID Numbers: STAGE-TB
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD that underlie results in a publication might be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut Germans Trias i Pujol:
tuberculosis, infectious diseases
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections