Design of an Integrative Algorithm for Staging Tuberculosis

Tuberculosis Clinical Trial

— STAGE-TB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03691883
• Other study ID #: STAGE-TB
• Status: Recruiting
• Start date: April 19, 2018
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Fundació Institut Germans Trias i Pujol
• Contact: Cris Vilaplana, MD, PhD
• Phone: 934978677
• Email: cvilaplana[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron-Drassanes	Barcelona
Spain	Servicios Clínicos de Barcelona	Barcelona
Spain	Hospital Sant Joan de Déu	Esplugues De Llobregat	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Fundació Institut Germans Trias i Pujol	Germans Trias i Pujol Hospital, Hospital del Mar, Hospital Sant Joan de Deu, Hospital Universitari Vall d'Hebron (Drassanes), Servicios Clínicos de Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Pujol-Cruells A, Vilaplana C. Specific Interventions for Implementing a Patient-Centered Approach to TB Care in Low-Incidence Cities. Front Med (Lausanne). 2019 Nov 26;6:273. doi: 10.3389/fmed.2019.00273. eCollection 2019. — View Citation

Romero-Tamarit A, Valles X, Munar-Garcia M, Espinosa-Pereiro J, Saborit N, Tortola MT, Stojanovic Z, Roure S, Antuori A, Cardona PJ, Soriano-Arandes A, Martin-Nalda A, Espiau M, de Souza-Galvao ML, Jimenez MA, Noguera-Julian A, Molina I, Casas X, Dominguez-Alvarez M, Jove N, Gogichadze N, L Fonseca K, Arias L, Millet JP, Sanchez-Montalva A, Vilaplana C. A longitudinal prospective study of active tuberculosis in a Western Europe setting: insights and findings. Infection. 2024 Apr;52(2):611-623. doi: 10.1007/s15010-024-02184-2. Epub 2024 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical changes	Changes in clinical status	timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Primary	Microbiological changes	Changes in microbiological cultures	timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Secondary	Changes in Biomarkers values	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)
Secondary	Radiological Score Value	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)
Secondary	Changes in SGRQ score	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)
Secondary	Changes in Kessler-10 score	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)
Secondary	Changes in Health Quality of Life measures along time using BCN-Q questionnaire	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)

External Links

•   This is the web site of the research group