Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA

Not yet recruiting

• Conditions: Tuberculosis, Pleural

• Registration Number: NCT06439810
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Inclusion Criteria:<br><br> - New-onset pleural effusion planning for thoracentesis<br><br> - Age 18 years or above<br><br> - Able to give informed consent<br><br>Exclusion Criteria:<br><br> - History of TBP or intrapleural therapy (including talc and fibrinolytic) in the<br> ipsilateral pleural space. Patients with a history of TB outside the pleural space<br> completed anti-TB treatment can be included<br><br> - History of surgical intervention (including decortication, pleurodesis, lung<br> resection) in the ipsilateral pleural space<br><br> - Concomitant use of at least two anti-TB medications (including isoniazid,<br> rifampicin, pyrazinamide, ethambutol, amikacin, streptomycin, levofloxacin,<br> moxifloxacin, linezolid) for more than consecutive 7 days in the past 3 months<br><br> - Consent not obtained from the participants

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of the new MTB cfDNA assay

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of the new MTB cfDNA assay;Clinical factors that may affect the levels of MTB cfDNA in TBP;Diagnostic performance of the new MTB cfDNA assay (drug resistant TB)