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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Imperial College Healthcare NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.