TuberculosisTrUSTNCT05423847
Triage UltraSound in Tb Endemic Regions
An observational study of Tuberculosis and Lower Resp Tract Infection, run by Centre Hospitalier Universitaire Vaudois at 3 sites in 3 countries.
Trial summary
In Sub-Saharan Africa, lower respiratory tract infections (LRTIs) and tuberculosis (TB) jointly are the leading cause of overall mortality. There is a need to integrate sustainable triage and management strategies into standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Lower Resp Tract Infection, Pneumonia
- What is being tested?
- POCUS
- How many people
- 504 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 14 Oct 2021to 10 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Benin: 6'500 cumulative total detected and declared COVID-19 cases since march 2020 to date (NB true COVID-19 incidence unknown due to undertesting), TB incidence 55/100'000/year, low HIV (prevalence < 2%) * South Africa: 1,522'697 cumulative total detected and declared COVID-19 cases since march 2020 to date TB incidence 615/100.000/year, high HIV (prevalence approximately 20%) * Mali: 30'420 cumulative total detected and declared COVID-19 cases since march 2020 to date (NB true COVID-19 incidence unknown due to undertesting), TB incidence 52/100'000/year, low HIV (prevalence < 2%)
Who may be able to join
- Age ≥18 years
- Suspicion of lower respiratory tract infection (defined as presence of cough with at least one of the following: fever, dyspnea/tachypnea, sputum production, chest pain, hemoptysis or cachexia)
Who cannot join
- Cough/dyspnea from a definite non-infectious origin (cardiac, asthmatic...)
- Inability to cooperate with ultrasound procedure
- Inability to sign informed consent (third witness procedure available for illiterate patients)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Point-of-care Ultrasound for the Diagnosis and Risk Stratification of Lower Respiratory Tract Infections in TB Endemic Regions: a Multicenter Prospective Cohort Study
In Sub-Saharan Africa, lower respiratory tract infections (LRTIs) and tuberculosis (TB) jointly are the leading cause of overall mortality. There is a need to integrate sustainable triage and management strategies into standard care. The TrUST study investigates the utility of point-of-care ultrasound (POCUS) for diagnosis and prognosis of LRTIs in TB endemic regions in the outpatient triage setting. Automated interpretation of POCUS by artificial intelligence (AI) may further standardize and improve its predictive utility as well as facilitate its implementation into usual practice.
Read the detailed description
Design International multicentre prospective cohort study
Setting This study aims to explore the performance of POCUS in a pre-hospital setting in countries with different prevalences of HIV: South- Africa (high prevalence), Benin (low prevalence) and Mali (low prevalence).
Study procedures Pre-recruitment training Before initiating the study, participating clinicians will benefit from lung ultrasound (LUS) and POCUS protocols for extra pulmonary TB (FASH+ exam) training with a field expert. The participating clinicians are required to pass a final expert test before start of patient recruitment and to have a minimum of 20 supervised US.
Inclusion (Day 0) Patients inclusion will be performed over a period of 18 to maximum 24 months. Recruitment will stop before the anticipated end if the inclusion of 1000 patients is reached.
Clinical data Data collected include demographic characteristics (age, sex, occupation etc.), past medical history (previous TB, Coronavirus Disease (COVID), vaccination status, documented past episodes of COVID-19, HIV status,…), symptoms (respiratory symptoms, specific COVID-19 symptoms (from the Centers for Disease Control COVID checklist), specific pulmonary TB symptoms (from the CDC TB checklist) and routine clinical examination findings (vital parameters, oxygen saturation, lung auscultation,…).
Laboratory analyses
Analyses performed on site:
- HIV screening with a serial two rapid test algorithm as per World Health Organization (WHO) guidelines : Screening with Alere Determine combo®; if positive, confirmation by a second rapid test First Response® HIV 1-2-0, CD4 count and/or Viral load as per national guidelines.
- Sputum for GeneXpert Mycobacterium Tuberculosis (MTB)/rifampicine (RIF) assay
- Induced sputum for a new GeneXpert MTB assay if a routine spot and second morning GeneXpert MTB is negative and sputum quality was low (salivary) as per WHO consolidated guidelines
- Sputum for Gram stain and standard bacteriological culture
- Nasopharyngeal swab for Severe Acute Respiratory Syndrome Coronovirus (SARS-CoV-2) real-time polymerase chain reaction (RT-PCR) (Cepheid Xpert Xpress SARS-CoV-2) Since the additional diagnostic yield of mycobacterial culture is shown to be very low in adult patients with cough in Benin, it is reserved for GenXpert MTB/RIF resistant cases, specimens other than sputum (e.g. pleural effusions, where sensitivity of GeneXpert MTB/RIF is low) and patients with treatment failure. Mycobacterial culture will be done on solid medium (Löwenstein-Jensen).
Analyses performed retrospectively on stored samples:
- Nasopharyngeal swab: PCR for influenza
- Sputum: syndromic molecular panel targeting influenza and atypical bacteria. Radiological examinations
- Chest X-Ray (CXR) - face: digital format will be stored
- LUS exam using a standard point-of-care ultrasound device (ultrasound-on-a-chip), LUS will be recorded according to a standard 12-point acquisition protocol with 4 additional apical sites (2 subclavicular and 2 axillary) for improved TB detection.
- This involves scanning both apexes, the anterior and posterior apexes, anterior superior, anterior inferior, posterior superior, posterior inferior and lateral thorax regions
- FASH plus exam using a standard point-of-care ultrasound device. The FASH plus protocol will be performed in a standardized manner as previously described.
All US images captured will be digitally recorded and transferred via a secured internet connection along with relevant metadata to a secure server for storage. For study quality control purposes, the quality of the image and the interpretation of a random sample of images will be evaluated retrospectively by an experienced radiologist.
Clinician-evaluated LUS and FASH All LUS and FASH exams will be read by 2 independent readers blinded to patients diagnosis and outcome. A third reader will solve discrepancies between the two readers. They will fill in a standardized LUS and FASH report.
AI-evaluated LUS and FASH The US images will be further used for secondary studies developing deep learning algorithms for LUS and FASH diagnosis.
Follow-up (D7 and D28) Patients will receive a follow-up phone call by the study nurse on day 7 and day 28. Data on the clinical evolution are collected: hospitalization, non-invasive ventilation, intubation, death.
Follow-up of TB treatment failures and deaths until D180 TB patients will be followed in the national TB register and treatment failures will be recorded at 6 months of treatment (according to national guidelines).
Deaths will be recorded until D180 as well.
- Conditions
- Tuberculosis, Lower Resp Tract Infection, Pneumonia
- Being tested
- POCUS
- Medical subject headings
- Tuberculosis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUSDiagnostic test
POCUS of lungs, pericardium and abdomen
| Study group | Role | What they receive |
|---|---|---|
| Benin1 | Benin urban recruitment site National teaching hospital for tuberculosis, outpatient emergency department Receives: Diagnostic Test: POCUS | |
| Mali1 | Mali urban recruitment site University Hospital Bamako, outpatient emergency department Receives: Diagnostic Test: POCUS | |
| South-Africa1 | South-Africa rural recruitment site 1 Tintswalo hospital, outpatient emergency department Receives: Diagnostic Test: POCUS | |
| South-Africa2 | South-Africa rural recruitment site 2 Zithulele hospital, outpatient emergency department Receives: Diagnostic Test: POCUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of LUS for the detection of TB
For LUS, each lung quadrant will be scored using a 6 feature LUS score (modified Soldati score) ranging from 1 (aerated lung), 2 (interstitial syndrome), 3 (sub centimeter pleural lesions), 4 (lung consolidation), 5 (pleural effusion) to 6 (pneumothorax). Sensitivity of LUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards
Measured: 18 to 24 months
Specificity of LUS for the detection of TB
For LUS, each lung quadrant will be scored using a 6 feature LUS score (modified Soldati score) ranging from 1 (aerated lung), 2 (interstitial syndrome), 3 (sub centimeter pleural lesions), 4 (lung consolidation), 5 (pleural effusion) to 6 (pneumothorax). Sensitivity of LUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards
Measured: 18 to 24 months
Sensitivity of FASH PLUS for the detection of TB
For the pericardial and abdominal ultrasound, a score according to the FASH PLUS protocol will be attributed ranging from 0 (no pathology) to 6 (presence of pericardial effusion, abdominal adenopathies, pleural effusion, splenic lesions, hepatic lesions, ascites). Sensitivity of FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Measured: 24 to 36 months
Specificity of FASH PLUS for the detection of TB
For the pericardial and abdominal ultrasound, a score according to the FASH PLUS protocol will be attributed ranging from 0 (no pathology) to 6 (presence of pericardial effusion, abdominal adenopathies, pleural effusion, splenic lesions, hepatic lesions, ascites). Specificity of FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Measured: 24 to 36 months
Sensitivity of combined LUS and FASH PLUS features for the detection of TB
Sensitivity of combined LUS and FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Measured: 24 to 36 months
Specificity of combined LUS and FASH PLUS features for the detection of TB
Specificity of combined LUS and FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Measured: 24 to 36 months
Sensitivity of AI-interpreted LUS for the detection of TB
LUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Sensitivity of AI-assisted interpretation LUS for the detection of TB using microbiological tests as reference standards
Measured: 24 to 36 months
Specificity of AI-interpreted LUS for the detection of TB
LUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Specificity of AI-assisted interpretation LUS for the detection of TB using microbiological tests as reference standards
Measured: 24 to 36 months
Sensitivity of AI-interpreted FASH PLUS for the detection of TB
FASH PLUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Sensitivity of FASH PLUS for the detection of TB using microbiological tests as reference standards
Measured: 24 to 36 months
Specificity of AI-interpreted FASH PLUS for the detection of TB
FASH PLUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Specificity of FASH PLUS for the detection of TB using microbiological tests as reference standards
Measured: 24 to 36 months
Secondary outcomes (2)
Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of POCUS
Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of POCUS to assess its feasibility, sustainability and acceptability
Measured: 12 months
Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of AI clinical decision support
Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of AI clinical decision support to assess its feasibility, sustainability and acceptability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start14 Oct 2021
- Primary completion11 Aug 2023
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital for tuberculosis, Cotonou, Benin, Ecole Polytechnique Fédérale de Lausanne, University of Witwatersrand, South Africa, National University Hospital (CNHU point G), Bamako, Mali
- Responsible party
- Principal investigator, Dr Boillat-Blanco Noemie, Centre Hospitalier Universitaire Vaudois
- Investigators
- Mary-Anne Hartley, MD-PhD, Principal investigator, Ecole Polytechnique Fédérale de LausanneNoémie Boillat Blanco, MD-PhD, Principal investigator, University of Lausanne HospitalsVeronique Suttels, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423847
- Sponsor's protocol ID
- CGRB11362
- Acronym
- TrUST
- Status last verified
- Aug 2023
- First submitted
- 20 Mar 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Ultrasound for the Diagnosis and Risk Stratification of Lower Respiratory Tract Infections in TB Endemic Regions: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05423847
- Acronym / sponsor ID
- TrUST / CGRB11362
- Conditions
- Tuberculosis, Lower Resp Tract Infection, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- National University Hospital for tuberculosis, Cotonou, Benin, Ecole Polytechnique Fédérale de Lausanne, University of Witwatersrand, South Africa, National University Hospital (CNHU point G), Bamako, Mali
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 21 Jun 2022 (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.
In Sub-Saharan Africa, lower respiratory tract infections (LRTIs) and tuberculosis (TB) jointly are the leading cause of overall mortality. There is a need to integrate sustainable triage and management strategies into standard care. The TrUST study investigates the utility of point-of-care ultrasound (POCUS) for diagnosis and prognosis of LRTIs in TB endemic regions in the outpatient triage setting. Automated interpretation of POCUS by artificial intelligence (AI) may further standardize and improve its predictive utility as well as facilitate its implementation into usual practice.
Detailed description
Design International multicentre prospective cohort study
Setting This study aims to explore the performance of POCUS in a pre-hospital setting in countries with different prevalences of HIV: South- Africa (high prevalence), Benin (low prevalence) and Mali (low prevalence).
Study procedures Pre-recruitment training Before initiating the study, participating clinicians will benefit from lung ultrasound (LUS) and POCUS protocols for extra pulmonary TB (FASH+ exam) training with a field expert. The participating clinicians are required to pass a final expert test before start of patient recruitment and to have a minimum of 20 supervised US.
Inclusion (Day 0) Patients inclusion will be performed over a period of 18 to maximum 24 months. Recruitment will stop before the anticipated end if the inclusion of 1000 patients is reached.
Clinical data Data collected include demographic characteristics (age, sex, occupation etc.), past medical history (previous TB, Coronavirus Disease (COVID), vaccination status, documented past episodes of COVID-19, HIV status,…), symptoms (respiratory symptoms, specific COVID-19 symptoms (from the Centers for Disease Control COVID checklist), specific pulmonary TB symptoms (from the CDC TB checklist) and routine clinical examination findings (vital parameters, oxygen saturation, lung auscultation,…).
Laboratory analyses
Analyses performed on site:
- HIV screening with a serial two rapid test algorithm as per World Health Organization (WHO) guidelines : Screening with Alere Determine combo®; if positive, confirmation by a second rapid test First Response® HIV 1-2-0, CD4 count and/or Viral load as per national guidelines.
- Sputum for GeneXpert Mycobacterium Tuberculosis (MTB)/rifampicine (RIF) assay
- Induced sputum for a new GeneXpert MTB assay if a routine spot and second morning GeneXpert MTB is negative and sputum quality was low (salivary) as per WHO consolidated guidelines
- Sputum for Gram stain and standard bacteriological culture
- Nasopharyngeal swab for Severe Acute Respiratory Syndrome Coronovirus (SARS-CoV-2) real-time polymerase chain reaction (RT-PCR) (Cepheid Xpert Xpress SARS-CoV-2) Since the additional diagnostic yield of mycobacterial culture is shown to be very low in adult patients with cough in Benin, it is reserved for GenXpert MTB/RIF resistant cases, specimens other than sputum (e.g. pleural effusions, where sensitivity of GeneXpert MTB/RIF is low) and patients with treatment failure. Mycobacterial culture will be done on solid medium (Löwenstein-Jensen).
Analyses performed retrospectively on stored samples:
- Nasopharyngeal swab: PCR for influenza
- Sputum: syndromic molecular panel targeting influenza and atypical bacteria. Radiological examinations
- Chest X-Ray (CXR) - face: digital format will be stored
- LUS exam using a standard point-of-care ultrasound device (ultrasound-on-a-chip), LUS will be recorded according to a standard 12-point acquisition protocol with 4 additional apical sites (2 subclavicular and 2 axillary) for improved TB detection.
- This involves scanning both apexes, the anterior and posterior apexes, anterior superior, anterior inferior, posterior superior, posterior inferior and lateral thorax regions
- FASH plus exam using a standard point-of-care ultrasound device. The FASH plus protocol will be performed in a standardized manner as previously described.
All US images captured will be digitally recorded and transferred via a secured internet connection along with relevant metadata to a secure server for storage. For study quality control purposes, the quality of the image and the interpretation of a random sample of images will be evaluated retrospectively by an experienced radiologist.
Clinician-evaluated LUS and FASH All LUS and FASH exams will be read by 2 independent readers blinded to patients diagnosis and outcome. A third reader will solve discrepancies between the two readers. They will fill in a standardized LUS and FASH report.
AI-evaluated LUS and FASH The US images will be further used for secondary studies developing deep learning algorithms for LUS and FASH diagnosis.
Follow-up (D7 and D28) Patients will receive a follow-up phone call by the study nurse on day 7 and day 28. Data on the clinical evolution are collected: hospitalization, non-invasive ventilation, intubation, death.
Follow-up of TB treatment failures and deaths until D180 TB patients will be followed in the national TB register and treatment failures will be recorded at 6 months of treatment (according to national guidelines).
Deaths will be recorded until D180 as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Benin1 | – | Diagnostic Test: POCUSBenin urban recruitment site National teaching hospital for tuberculosis, outpatient emergency department |
| Mali1 | – | Diagnostic Test: POCUSMali urban recruitment site University Hospital Bamako, outpatient emergency department |
| South-Africa1 | – | Diagnostic Test: POCUSSouth-Africa rural recruitment site 1 Tintswalo hospital, outpatient emergency department |
| South-Africa2 | – | Diagnostic Test: POCUSSouth-Africa rural recruitment site 2 Zithulele hospital, outpatient emergency department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Benin: 6'500 cumulative total detected and declared COVID-19 cases since march 2020 to date (NB true COVID-19 incidence unknown due to undertesting), TB incidence 55/100'000/year, low HIV (prevalence < 2%) * South Africa: 1,522'697 cumulative total detected and declared COVID-19 cases since march 2020 to date TB incidence 615/100.000/year, high HIV (prevalence approximately 20%) * Mali: 30'420 cumulative total detected and declared COVID-19 cases since march 2020 to date (NB true COVID-19 incidence unknown due to undertesting), TB incidence 52/100'000/year, low HIV (prevalence < 2%)
Key inclusion criteria (2 listed)
- Age ≥18 years
- Suspicion of lower respiratory tract infection (defined as presence of cough with at least one of the following: fever, dyspnea/tachypnea, sputum production, chest pain, hemoptysis or cachexia)
Key exclusion criteria (3 listed)
- Cough/dyspnea from a definite non-infectious origin (cardiac, asthmatic...)
- Inability to cooperate with ultrasound procedure
- Inability to sign informed consent (third witness procedure available for illiterate patients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCUSPOCUS of lungs, pericardium and abdomen | Diagnostic test | Benin1, Mali1, South-Africa1, South-Africa2 |
Primary outcome
Sensitivity of LUS for the detection of TB
Time frame: 18 to 24 months
For LUS, each lung quadrant will be scored using a 6 feature LUS score (modified Soldati score) ranging from 1 (aerated lung), 2 (interstitial syndrome), 3 (sub centimeter pleural lesions), 4 (lung consolidation), 5 (pleural effusion) to 6 (pneumothorax). Sensitivity of LUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards
Specificity of LUS for the detection of TB
Time frame: 18 to 24 months
For LUS, each lung quadrant will be scored using a 6 feature LUS score (modified Soldati score) ranging from 1 (aerated lung), 2 (interstitial syndrome), 3 (sub centimeter pleural lesions), 4 (lung consolidation), 5 (pleural effusion) to 6 (pneumothorax). Sensitivity of LUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards
Sensitivity of FASH PLUS for the detection of TB
Time frame: 24 to 36 months
For the pericardial and abdominal ultrasound, a score according to the FASH PLUS protocol will be attributed ranging from 0 (no pathology) to 6 (presence of pericardial effusion, abdominal adenopathies, pleural effusion, splenic lesions, hepatic lesions, ascites). Sensitivity of FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Specificity of FASH PLUS for the detection of TB
Time frame: 24 to 36 months
For the pericardial and abdominal ultrasound, a score according to the FASH PLUS protocol will be attributed ranging from 0 (no pathology) to 6 (presence of pericardial effusion, abdominal adenopathies, pleural effusion, splenic lesions, hepatic lesions, ascites). Specificity of FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Sensitivity of combined LUS and FASH PLUS features for the detection of TB
Time frame: 24 to 36 months
Sensitivity of combined LUS and FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Specificity of combined LUS and FASH PLUS features for the detection of TB
Time frame: 24 to 36 months
Specificity of combined LUS and FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Sensitivity of AI-interpreted LUS for the detection of TB
Time frame: 24 to 36 months
LUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Sensitivity of AI-assisted interpretation LUS for the detection of TB using microbiological tests as reference standards
Specificity of AI-interpreted LUS for the detection of TB
Time frame: 24 to 36 months
LUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Specificity of AI-assisted interpretation LUS for the detection of TB using microbiological tests as reference standards
Sensitivity of AI-interpreted FASH PLUS for the detection of TB
Time frame: 24 to 36 months
FASH PLUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Sensitivity of FASH PLUS for the detection of TB using microbiological tests as reference standards
Specificity of AI-interpreted FASH PLUS for the detection of TB
Time frame: 24 to 36 months
FASH PLUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Specificity of FASH PLUS for the detection of TB using microbiological tests as reference standards
2 secondary outcomes
Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of POCUS
Time frame: 12 months
Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of AI clinical decision support
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mary-Anne Hartley, MD-PhD principal investigator
Ecole Polytechnique Fédérale de Lausanne
Noémie Boillat Blanco, MD-PhD principal investigator
University of Lausanne Hospitals
Veronique Suttels, MD principal investigator
University of Lausanne Hospitals
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Lower Resp Tract Infection, run by Centre Hospitalier Universitaire Vaudois at 3 sites in 3 countries.
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 3 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: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Benin, Mali, South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of LUS for the detection of TB (time frame: 18 to 24 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2025.