TB PCR in BAL and EBUS-TBNA

NCT04909385 | Completed

• 1 other identifier: 266798
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 1

Brief 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

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• The diagnostic performance of Xpert Ultra in BAL and EBUS_TBNA

  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,

  Through study completion, an average of 1 year

Study Arms (2)

Bronchoalveolar lavage (BAL) samples for pulmonary TB

(EBUS-TBNA) samples for mediastinal TB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study aims to recruit a minimum of 323 participants undergoing a BAL, and 323 participants undergoing an EBUS-TBNA for a minimum of 6 months or until the recruitment targets are reached

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Chelsea and Westminster NHS Foundation Trust: collaborator
• The Hillingdon Hospitals NHS Foundation Trust: collaborator
• Barts & The London NHS Trust: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• University Hospitals, Leicester: collaborator
• Manchester University NHS Foundation Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• London North West University Health Care NHS Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: June 1, 2021
• Study Start: January 15, 2021
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)