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TB PCR in BAL and EBUS-TBNA

NCT04909385 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 394

Last updated 2025-01-22

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Chelsea and Westminster NHS Foundation Trust

    collaborator OTHER

  • The Hillingdon Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • Barts & The London NHS Trust

    collaborator OTHER

  • University Hospital Birmingham NHS Foundation Trust

    collaborator OTHER

  • University Hospitals, Leicester

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • Royal Free Hospital NHS Foundation Trust

    collaborator OTHER

  • London North West University Health Care NHS Trust

    collaborator UNKNOWN

  • Imperial College Healthcare NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909385 on ClinicalTrials.gov