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

Status: Active_not_recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients hospitalized for unilateral pleural effusion.

• Pleural tapping will be performed for pleural fluid analysis.

• Aged 18 years old or above

Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
Hong Kong
Time Frame
Start Date: 2022-09-01
Completion Date: 2025-12-31
Participants
Target number of participants: 329
Treatments
TBP
Patients with definite or probable tuberculous pleuritis
Non-TBP
Patients without tuberculous pleuritis
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov