NCT04909385Completed
TB PCR in BAL and EBUS-TBNA
Xpert MTB/RIF Ultra Assay for the Detection of Mycobacterium Tuberculosis (MTB) in Bronchoalveolar Lavage (BAL) for Pulmonary TB and Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) Samples for Mediastinal TB
Source: ClinicalTrials.gov · Last updated 22 Jan 2025
Brief summary (registry, in English)
This prospective observational multi-centre UK study will evaluate Xpert MTB/RIF Ultra for the detection of Mycobacterium tuberculosis (MTB) in bronchoalveolar lavage (BAL) samples for pulmonary TB and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) samples for mediastinal TB and compare the diagnostic performance against conventional modalities (smear, culture, cytology) as well as to a clinical composite diagnosis. This will be using a clinical expert panel reviewing data blindly. The Investigators will assess the performance of Xpert Ultra by calculating the sensitivity, specificity, positive predictive and negative predictive value in UK centres. The turn-around time of these modality and its effect on treatment decisions will be assessed. Finally the Investigators will correlate different clinical characteristics and to define the sensitivities in the various clinical presentations and to evaluate the phenotypes of patients with 'trace' results within these cohorts.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 394 (actual)
- First submitted
- 23 Mar 2021
- Start date
- 15 Jan 2021
- Primary completion date
- 29 Feb 2024
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Diseases
- Tuberculosis
- NCT number
- NCT04909385
What you commit to
- Study type: Observational
- Participants enrolled: 394
- From 15 Jan 2021 to the primary completion date, 29 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.