Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA in Hong Kong

Launched by CHINESE UNIVERSITY OF HONG KONG · Oct 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose tuberculous pleuritis (TBP), a type of tuberculosis (TB) that affects the space around the lungs. TB is a serious infectious disease that is quite common in Hong Kong. Traditional tests for TBP can be difficult and sometimes painful because they often require taking samples through invasive procedures like a pleural biopsy. This trial will explore the use of a new test that looks for Mycobacterium tuberculosis cell-free DNA (cfDNA) in pleural fluid. This test aims to improve the diagnosis of TBP by using a less invasive method, making it easier for patients.

To be eligible for this trial, participants must be at least 18 years old and hospitalized for a new case of fluid buildup in one lung (unilateral pleural effusion) without signs of fluid overload. They will need to undergo a procedure called thoracentesis, where a needle is used to collect pleural fluid for analysis. Participants in this study will have the opportunity to help researchers determine if this new test can accurately diagnose TBP, potentially leading to quicker and less invasive diagnostic options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients hospitalised for new-onset unilateral pleural effusion.
• • No clinical evidence of fluid overload.
• • Thoracentesis will be performed for pleural fluid analysis.
• • Age equals or is above 18 years old
• Exclusion Criteria:
• • Recurrent pleural effusion with known aetiology.
• • History of intrapleural therapy (including talc and fibrinolytic), surgical decortication or surgical pleurodesis in the ipsilateral pleural space
• • Concomitant use of at least two anti-TB medications (including isoniazid, rifampicin, pyrazinamide, ethambutol, amikacin, streptomycin, levofloxacin, moxifloxacin, linezolid) for more than consecutive 7 days in the past 3 months
• • Failed to obtain informed consent due to patient's refusal or cognitive impairment.
• • History of pulmonary tuberculosis or extrapulmonary tuberculosis
• • Expected survival of less than three months from a different pathology (e.g. advanced metastatic malignancy) as that further pleural investigations may not be able to carry out if negative initial workup.
• • Use of agents under research or not registered in the 30 days prior to the study