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NCT Number: NCT03691883

Design of an Integrative Algorithm for Staging Tuberculosis

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Disease Attributes Gram-Positive Bacterial Infections Infections Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Study contacts

Contact information is provided by the study sponsor or research team.

Cris Vilaplana, MD, PhD

CONTACT

[email protected]

934978677

Laura Villegas

CONTACT

[email protected]

+34934978681

Sponsors and collaborators

Lead sponsor

Fundació Institut Germans Trias i Pujol

Other

Collaborators

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

Registry information

Official study title

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

Acronym: STAGE-TB

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2018
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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