TuberculosisSTAGE-TBNCT03691883
Design of an Integrative Algorithm for Staging Tuberculosis
An observational study of Tuberculosis, run by Fundació Institut Germans Trias i Pujol at 5 sites in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- How many people
- 200 participants
- Where
- 5 sitesSpain
- Study dates
- 19 Apr 2018to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not consenting to data/samples donation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Zoran Stojanovic, MD, PhD
Cristina Prat, MD, PhD
- Recruiting
Hospital del Mar
Barcelona, 08003
Neus Jové, MD
Neus Jové, MD
- Recruiting
Hospital Universitari Vall d'Hebron-Drassanes
Barcelona
Adrián Sánchez, MD, PhD
Adrián Sánchez, MD, PhD
- Recruiting
Servicios Clínicos de Barcelona
Barcelona
Joan Pau Millet
Joan Pau Millet, MD, PhD
- Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Antoni Noguera, MD, PhD
Antoni Noguera, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, infectious diseases
- Medical subject headings
- Tuberculosis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Clinical changes
Changes in clinical status
Measured: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Microbiological changes
Changes in microbiological cultures
Measured: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Secondary outcomes (5)
Changes in Biomarkers values
Changes in the biomarkers along time assessed by using analyzing parameters in blood and urine samples (by ELISA and LUMINEX)
Measured: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
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.
Measured: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
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.
Measured: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
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.
Measured: 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
Changes in Health Quality of Life measures along time using BCN-Q questionnaire (descriptive questionnaire).
Measured: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start19 Apr 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron (Drassanes), Servicios Clínicos de Barcelona, Germans Trias i Pujol Hospital, Hospital Sant Joan de Deu, Hospital del Mar
- Responsible party
- Sponsor
- Investigators
- Cris Vilaplana, MD, PhD, Principal investigator, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691883
- Sponsor's protocol ID
- STAGE-TB
- Acronym
- STAGE-TB
- Status last verified
- Dec 2024
- First submitted
- 3 Sep 2017
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD that underlie results in a publication might be shared with other researchers
Publications
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.
PubMed 38349459Roure S, Valles X, Sopena N, Benitez RM, Reynaga EA, Bracke C, Loste C, Mateu L, Antuori A, Baena T, Portela G, Llussa J, Flamarich C, Soldevila L, Tenesa M, Perez R, Plasencia E, Bechini J, Pedro-Botet ML, Clotet B, Vilaplana C. Disseminated tuberculosis and diagnosis delay during the COVID-19 era in a Western European country: a case series analysis. Front Public Health. 2023 May 18;11:1175482. doi: 10.3389/fpubh.2023.1175482. eCollection 2023.
PubMed 37275492Pujol-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.
PubMed 31850353
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of an Integrative Algorithm for Staging Tuberculosis to Improve Clinical Management.
- ClinicalTrials.gov ID
- NCT03691883
- Acronym / sponsor ID
- STAGE-TB / STAGE-TB
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, infectious diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron (Drassanes), Servicios Clínicos de Barcelona, Germans Trias i Pujol Hospital, Hospital Sant Joan de Deu, Hospital del Mar
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not consenting to data/samples donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical changes
Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Changes in clinical status
Microbiological changes
Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Changes in microbiological cultures
5 secondary outcomes
Changes in Biomarkers values
Time frame: 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 SGRQ score
Time frame: 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 using BCN-Q questionnaire
Time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 38349459Romero-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.
- Background: PubMed 37275492Roure S, Valles X, Sopena N, Benitez RM, Reynaga EA, Bracke C, Loste C, Mateu L, Antuori A, Baena T, Portela G, Llussa J, Flamarich C, Soldevila L, Tenesa M, Perez R, Plasencia E, Bechini J, Pedro-Botet ML, Clotet B, Vilaplana C. Disseminated tuberculosis and diagnosis delay during the COVID-19 era in a Western European country: a case series analysis. Front Public Health. 2023 May 18;11:1175482. doi: 10.3389/fpubh.2023.1175482. eCollection 2023.
- Results publication: PubMed 31850353Pujol-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.
- Institutional webpage- Experimental TB UnitLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. IPD that underlie results in a publication might be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cris Vilaplana, MD, PhD principal investigator
Fundació Institut Germans Trias i Pujol
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Fundació Institut Germans Trias i Pujol at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cris Vilaplana, MD, PhD (934978677, cvilaplana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical changes (time frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691883, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.