Triage UltraSound in Tb Endemic Regions

NCT05423847 | Completed FDA Device

• 1 other identifier: CGRB11362
• Study Type: observational
• Target: 504
• Locations: 3 countries
• Sites: 3

Brief 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. 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.

Conditions

Tuberculosis; Lower Resp Tract Infection; Pneumonia

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

  12 months

Study Arms (4)

Benin1

Benin urban recruitment site National teaching hospital for tuberculosis, outpatient emergency department

Diagnostic Test: POCUS

Mali1

Mali urban recruitment site University Hospital Bamako, outpatient emergency department

Diagnostic Test: POCUS

South-Africa1

South-Africa rural recruitment site 1 Tintswalo hospital, outpatient emergency department

Diagnostic Test: POCUS

South-Africa2

South-Africa rural recruitment site 2 Zithulele hospital, outpatient emergency department

Diagnostic Test: POCUS

Interventions

POCUS DIAGNOSTIC_TEST

POCUS of lungs, pericardium and abdomen

Benin1; Mali1; South-Africa1; South-Africa2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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%)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• National University Hospital for tuberculosis, Cotonou, Benin: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• University of Witwatersrand, South Africa: collaborator
• National University Hospital (CNHU point G), Bamako, Mali: collaborator

Study Sites (3)

CNHUPPC

Cotonou, Atlantic, Benin

Location

CHU point G

Bamako, Mali

Location

Wits Rural University

Acornhoek, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood Plasma Urine Nasopharyngeal swab Oropharyngeal swab Sputum

MeSH Terms

Conditions

Tuberculosis; Pneumonia

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mary-Anne Hartley, MD-PhD

  Ecole Polytechnique Fédérale de Lausanne

  PRINCIPAL INVESTIGATOR

• Noémie Boillat Blanco, MD-PhD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

• Veronique Suttels, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: June 21, 2022
• Study Start: October 14, 2021
• Primary Completion: August 11, 2023
• Study Completion: February 10, 2025
• Last Updated: February 13, 2025

Record last verified: 2023-08

Locations

ZA (1); BE (1); MA (1)