An observational study in Tuberculosis, Lower Resp Tract Infection and Pneumonia, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Centre Hospitalier Universitaire Vaudois · Observational
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.
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:
Analyses performed retrospectively on stored samples:
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 504 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 208 studies on the registry; 48 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Benin urban recruitment site National teaching hospital for tuberculosis, outpatient emergency department
Diagnostic Test: POCUS
Mali urban recruitment site University Hospital Bamako, outpatient emergency department
Diagnostic Test: POCUS
South-Africa rural recruitment site 1 Tintswalo hospital, outpatient emergency department
Diagnostic Test: POCUS
South-Africa rural recruitment site 2 Zithulele hospital, outpatient emergency department
Diagnostic Test: POCUS
POCUS of lungs, pericardium and abdomen
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 to 36 months
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
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
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
Time frame: 12 months
Plan to share: Undecided
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