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Search / Trial NCT05397730

MTB cfDNA Levels in TBP

Launched by CHINESE UNIVERSITY OF HONG KONG · May 25, 2022

Trial Information

Current as of August 28, 2025

Recruiting

Keywords

Tuberculosis, Tuberculous Pleuritis, Cell Free Dna

ClinConnect Summary

This clinical trial is studying a new way to diagnose tuberculous pleuritis (TBP), which is a type of tuberculosis that affects the lining of the lungs. Diagnosing TBP can be difficult because traditional methods, such as testing fluid from the lungs, are not always accurate. The trial will look at a new test that checks for Mycobacterium tuberculosis cell-free DNA (MTB cfDNA) in pleural fluid. Researchers believe this test may be better at identifying TBP compared to standard methods. By understanding the levels of MTB cfDNA, the study aims to help doctors diagnose TBP more quickly and reduce the need for more invasive procedures like pleural biopsies.

To participate in the trial, individuals must be 18 years or older and hospitalized with fluid buildup in one lung (unilateral pleural effusion). However, those who have had previous tuberculosis pleuritis, certain infections, or specific treatments in the same area may not be eligible. Participants will have a procedure to collect pleural fluid, which will then be tested alongside other diagnostic methods. This study is currently recruiting participants, and the results could lead to faster and more accurate diagnoses, ultimately improving treatment for those affected by TBP.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients hospitalized for unilateral pleural effusion.
  • Pleural tapping will be performed for pleural fluid analysis.
  • Aged 18 years old or above
  • Exclusion Criteria:
  • History of tuberculous pleuritis (TBP) and bacterial pleural infection, in either ipsilateral or contralateral pleural space.
  • History of intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space.
  • History of surgical decortication or pleurodesis in the ipsilateral pleural space
  • Use of anti-TB medications (including isoniazid, rifampicin, pyrazinamide, ethambutol, amikacin, streptomycin, levofloxacin, moxifloxacin, linezolid) for more than consecutive 7 days in the past 3 months.
  • On long-term local or systemic antibiotics.
  • Failed to obtain informed consent due to patient's refusal or cognitive impairment

About Chinese University Of Hong Kong

The Chinese University of Hong Kong (CUHK) is a prestigious research institution renowned for its commitment to advancing medical science and improving healthcare outcomes. As a clinical trial sponsor, CUHK leverages its extensive academic resources and interdisciplinary expertise to conduct innovative research that addresses critical health challenges. The university fosters collaboration among leading researchers, healthcare professionals, and industry partners, ensuring rigorous study design and implementation. CUHK is dedicated to upholding the highest ethical standards in clinical research, with a focus on translating findings into tangible benefits for patients and the broader community.

Locations

Hong Kong, , Hong Kong

Hong Kong, , Hong Kong

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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