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Clinical Trial NCT05397730 (MYDNITE) for Tuberculosis, Pleural is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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MTB cfDNA Levels in TBP (MYDNITE) 329 Confirmatory Trial

Active, not recruiting
Clinical Trial NCT05397730 (MYDNITE) is an observational study for Tuberculosis, Pleural that is active, not recruiting. It started on 1 September 2022 with plans to enroll 329 participants. Led by Chinese University of Hong Kong, it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 17 November 2025.
Brief Summary
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 lev...Show More
Detailed Description
Tuberculosis (TB) is one of the major global health threats, with an estimated global incidence of 9.87 million cases in 2020 and it is the second leading infectious cause of death after COVID-19. Apart from pulmonary involvement, which is the most common manifestation of TB, extrapulmonary TB (EPTB) affected 22.3% of TB patients in Hong Kong and was associated with a worse treatment outcome than pulmonary TB. Among ...Show More
Official Title

Levels of Mycobacterium Tuberculosis Cell-free DNA (MTB cfDNA) in Tuberculous and Non-tuberculous Pleural Effusion

Conditions
Tuberculosis, Pleural
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • MYDNITE
  • TBP_cfDNA_levels
NCT ID Number
NCT05397730
Start Date (Actual)
2022-09-01
Last Update Posted
2025-11-17
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
329
Study Type
Observational
Status
Active, not recruiting
Keywords
Tuberculosis, Tuberculous pleuritis, cell-free DNA
Arms / Interventions
Participant Group/ArmIntervention/Treatment
TBP
Patients with definite or probable tuberculous pleuritis
Mycobacterium tuberculosis (MTB) cell-free DNA (cf-DNA)
Comparing the diagnostic accuracy between MTB cfDNA and PCR on diagnosing tuberculous pleuritis
Non-TBP
Patients without tuberculous pleuritis
Mycobacterium tuberculosis (MTB) cell-free DNA (cf-DNA)
Comparing the diagnostic accuracy between MTB cfDNA and PCR on diagnosing tuberculous pleuritis
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The MTB cfDNA level in TBP and non-TB pleural effusions
The median MTB cfDNA level in TBP and non-TB pleural effusions
24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The diagnostic performance of MTB cfDNA and Xpert Ultra in diagnosing MTB culture-positive and MTB culture-negative TBP
Which includes sensitivity, specificity, positive predictive value, negative predictive value of these two tests in diagnosing TBP when comparing with the gold standard test
24 months
Clinical factors that may affect the levels of MTB cfDNA in TBP
which includes the mycobacterial culture result, level of inflammatory activity within the pleural space
24 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patients hospitalized for unilateral pleural effusion.
  • Pleural tapping will be performed for pleural fluid analysis.
  • Aged 18 years old or above

  • 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 14 days in the past 3 months.
  • Failed to obtain informed consent due to patient's refusal or cognitive impairment
Chinese University of Hong Kong logoChinese University of Hong Kong474 active studies to explore
Study Responsible Party
Ka Pang Chan, Principal Investigator, Doctor (Clinical Lecturer), Chinese University of Hong Kong
No contact data.
1 Study Locations in 1 Countries

Hong Kong

Prince of Wales Hospital, Hong Kong, Hong Kong, Hong Kong