Tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
This is a prospective multi-centre study across the UK including London, Birmingham, Leicester and Manchester which account for the highest proportion of TB cases in the UK. These are centres routinel
Sponsors
Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any consenting adult =18 years of age suspected of having pulmonary TB or mediastinal TB who is undergoing a routine clinical bronchoscopy or EBUS-TBNA
Exclusion criteria
Exclusion criteria: Any patient who has had a BAL or EBUS-TBNA but has not had Xpert Ultra testing as part of routine diagnostics for possible TB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic performance of Xpert Ultra in BAL and EBUS-TBNA samples in patients with suspected TB against conventional modalities available (smear microscopy, culture, cytology) using a subgroup analysis of the different clinical categories attributing to the likely TB diagnosis, measured at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Turn-around time for Xpert Ultra against standard smear, culture, cytology results and its effects on treatment decisions, measured using clinical, microbiological, cytological data, radiology and biomarkers of infection collected throughout the study 2. The operating characteristics of this platform in varying clinical phenotypes, evaluated by stratifying patients based on risk factors, clinical presentations, radiological appearances and histological results and comparing this with Xpert Ultra results (including ‘trace’) at a single timepoint | — |
Countries
England, United Kingdom
Outcome results
None listed