Evaluating cell-free DNA levels in patients with tuberculous pleuritis
Levels of Mycobacterium Tuberculosis Cell-free DNA (MTB cfDNA) in Tuberculous and Non-tuberculous Pleural Effusion
This study is testing if measuring cell-free DNA from tuberculosis bacteria in pleural fluid can help doctors diagnose tuberculous pleuritis more accurately and quickly, possibly avoiding the need for invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05397730 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the levels of Mycobacterium tuberculosis cell-free DNA (MTB cfDNA) in pleural fluid from patients diagnosed with tuberculous pleuritis (TBP) and other non-TBP conditions. By collecting pleural fluid samples and conducting tests including MTB culture, MTB cfDNA analysis, and MTB PCR, the study seeks to determine the diagnostic accuracy of MTB cfDNA compared to conventional methods. The goal is to establish a cutoff level for MTB cfDNA that could enhance the sensitivity of TBP diagnosis, potentially reducing the need for invasive procedures like pleural biopsy. If successful, this approach could lead to quicker diagnoses and more timely treatment for patients suffering from TBP.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 and older who are hospitalized for unilateral pleural effusion and are undergoing pleural fluid analysis.
Not a fit: Patients with a history of tuberculous pleuritis or bacterial pleural infection, or those who have received anti-TB medications recently, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and less invasive diagnostic method for tuberculous pleuritis, leading to faster treatment initiation.
How similar studies have performed: Preliminary data suggests that the use of MTB cfDNA has shown superior sensitivity compared to conventional diagnostic methods, indicating potential success in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Ka Pang Chan, MBChB
- Email: chankapang@gmail.com
- Phone: 35052211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.