HIV/AIDS Tuberculosis
Conditions
Interventions
Observation lung ultrasound
Sponsors
EPFL Technical University of Lausanne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General criteria Age = 12 years Presentation to a participating outpatient healthcare facility for any reason of care TB screening criteria (at least one required) Presumed TB, defined as the presence of = 1 TB-related symptom: • cough of any duration • fever • night sweats • weight loss and/or = 1 TB risk factor according to TUTT criteria: • HIV infection • TB contact (self-reported household or workplace contact within the previous 12 months) • prior TB (self-reported diagnosis within the previous 2 years)
Exclusion criteria
Exclusion criteria: Absence or withdrawal of informed consent: • for participants = 18 years: Inability or refusal to provide written informed consent • for participants aged 12-17 years: o Inability or refusal of a parent/legal guardian to provide written informed consent; and/or o Inability or refusal of the participant to provide written informed assent, where required by local ethics regulations Ongoing TB curative treatment Clinician decision due to poor general condition or requirement for immediate critical care Inability to cooperate with ultrasound procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective 1.1 Diagnostic accuracy of CAD-LUS for the detection of pulmonary TB using AI-aided interpretation against the primary microbiological reference standard (MRS) Primary endpoint and measures 1.1.1 Pulmonary TB as a binary outcome defined by the primary microbiological reference standard 1.1.2. CAD-LUS score of the acquisition protocol used into the continuation phase, dichotomized at relevant thresholds, with accuracy against the MRS expressed as sensitivity (score dichotomized at the 70% specificity threshold), specificity (score dichotomized at the 90% sensitivity threshold) and AUROC | — |
Secondary
| Measure | Time frame |
|---|---|
| Interim objective 0.1 Direct comparison of diagnostic accuracy of CAD-LUS on still images vs. blind sweep videos for detection of pulmonary TB as defined by the primary MRS Interim endpoint and measures 0.1.1 as 1.1.1 for the subgroup enrolled in blind sweep validation phase 0.1.2 CAD-LUS score generated on still images generated as part of the standardised 14-point LUS protocol, and dichotomized at relevant threshold as defined in 1.1.2 0.1.3 CAD-LUS score generated on videos generated as part of the blind sweep LUS protocol, and dichotomized at relevant threshold as defined in 1.1.2 ;Secondary objective 2.1 Diagnostic accuracy of CAD-LUS for the detection of pulmonary TB using AI-aided interpretation against the extended MRS Endpoints and measures 2.1.1 Pulmonary TB as a binary outcome defined by the extended MRS 2.1.2 as 1.1.2, dichotomized and with accuracy against the extended MRS.;Secondary objective 2.2 Diagnostic accuracy of CAD-LUS for the detection of pulmonary TB using AI-aided interpretation against the composite reference standard (CRS) Endpoints and measures 2.2.1 Pulmonary TB as a binary outcome defined by the CRS 2.2.2 As 1.1.2, dichotomized and with accuracy against the CRS;Secondary objective 2.2 Diagnostic accuracy of CAD-LUS for the detection of pulmonary TB using AI-aided interpretation against the composite reference standard (CRS) Endpoints and measures 2.2.1 Pulmonary TB as a binary outcome defined by the CRS 2.2.2 As 1.1.2, dichotomized and with accuracy against the CRS. ;Secondary objective 2.3 Direct comparison of diagnostic accuracy of CAD-LUS vs. CAD-CXR for detection of pulmonary TB as defined by the primary and the extended MRS Endpoints and measures 2.3.1 Pulmonary TB defined by i) primary MRS (endpoint 1.1.1) and ii) eMRS (endpoint 2.1.1) 2.3.2 as 1.1.2 and 2.1.2 2.3.3 Sensitivity, specificity and AUROC of CAD-CXR, similarly measured as a score, and dichotomized at the 70% specificity (for sensitivity) and 90% sensitivity (for spec | — |
Countries
Benin, Mali, South Africa
Contacts
Public ContactKhadidia Ouattara
Prof in pneumology
Outcome results
None listed