Pulmonary tuberculosis Infections and Infestations
Conditions
Interventions
This is a randomised diagnostic study. Consenting presumptive tuberculosis patients will be randomised to one of four lung ultrasound image acquisition protocol/probe combinations:
1. Comprehensive pr
Sponsors
NIHR Global Health Research Programme
Delft Diagnostics
Wellcome Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years and older consenting to enrolment 2. Presenting to the outpatient department, TB clinic, or ART clinic with symptoms suggestive of TB (cough>2 weeks plus at least one additional symptom including fever, night sweats, weight loss, or haemoptysis)
Exclusion criteria
Exclusion criteria: 1. Inability (or refusal) to give written informed consent 2. Current in-patient 3. Too unwell or unwilling to undergo study procedures 4. Known microbiologically confirmed PTB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy of LUS for PTB relative to Xpert® MTB/RIF Ultra will be measured using sensitivity and specificity for each protocol/probe combination at a single timepoint (baseline). A positive LUS is one that will have the presence of subpleural consolidation or consolidation or pathological B-line Sensitivity of LUS = true TB positives /true positives + false negatives (relative to GeneXpert) Specificity of LUS = true TB negatives/true TB negatives+ false TB positives (relative to GeneXpert) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity of LUS in HIV-positive compared with HIV-negative individuals: Sensitivity will be measured using the proportion of true positive cases correctly identified by lung ultrasound (LUS) in both HIV-positive and HIV-negative individuals. Measurements will be taken at baseline (single timepoint) 2. Specificity of LUS in patients with previous PTB compared with patients without previous PTB: Specificity will be measured using the proportion of true negative cases correctly identified by LUS in patients with and without previous pulmonary tuberculosis (PTB). Measurements will be taken at baseline (single timepoint) 3. LUS features predictive of PTB: Predictive features will be identified through human reader analysis of LUS images (specifically for the presence/absence of subpleural nodules, consolidations, cavities, pleural irregularities, and pathological B-lines). Measurements will be taken at baseline (single timepoint) and the sensitivity and specificity of each of these LUS features measured individually, as in 1 and 2 above. | — |
Countries
Zambia
Contacts
Public ContactJohn Kondwelani;Helen Mateyo;Ayles
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Outcome results
None listed