NCT05397730Completed
MTB cfDNA Levels in TBP
Levels of Mycobacterium Tuberculosis Cell-free DNA (MTB cfDNA) in Tuberculous and Non-tuberculous Pleural Effusion
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
Tuberculous pleuritis (TBP) is the most common manifestation of extrapulmonary TB. Its diagnosis is challenging due to the low sensitivity of mycobacterial culture from the pleural fluid and the need for invasive pleural biopsy. Preliminary data has shown the superior sensitivity of Mycobacterium tuberculosis cell-free DNA (MTB cfDNA) to conventional culture and MTB polymerase chain reaction (PCR), but the cutoff level of MTB cfDNA was not determined. This study involves a prospective collection of pleural fluid due to TBP and non-TBP aetiologies, with subsequent testing by MTB culture, MTB cfDNA and MTB PCR. The levels of MTB cfDNA in the pleural fluid will be correlated with different types of diagnosis, and its diagnostic accuracy will be compared with conventional culture and MTB PCR. A confirmatory study result of MTB cfDNA can shorten the time to diagnosis, reduce the need for pleural biopsy and prevent the delay of definitive treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 329 (actual)
- First submitted
- 23 May 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Tuberculosis
- NCT number
- NCT05397730
What you commit to
- Study type: Observational
- Participants enrolled: 329
- From 1 Sept 2022 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of anti-TB medications (including isoniazid, rifampicin, pyrazinamide, ethambutol, amikacin, streptomycin, levofloxacin, moxifloxacin, linezolid) for more than consecutive 14 days in the past 3 months.
Other illness
- 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
- Failed to obtain informed consent due to patient's refusal or cognitive impairment
Who the study is looking for
- Patients hospitalized for unilateral pleural effusion.
- Pleural tapping will be performed for pleural fluid analysis.
- Aged 18 years old or above
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
Related publications
- Sequencing of Pleural Fluid and Plasma for Tuberculous Pleuritis.NEJM Evid · 2026 · PMID 41874256
This page is information, not medical advice. Discuss any trial with your doctor.