Comparing a new test for tuberculosis with conventional tests
Not Applicable
- Conditions
- TuberculosisInfections and Infestations
- Registration Number
- ISRCTN35629189
- Lead Sponsor
- Imperial College Healthcare NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 646
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 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<br> 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<br>