Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390969
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
TBP Survey Among Respiratory Physicians
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Survey on the Practice and Interpretation of Various Diagnostic Tests for Tuberculous Pleuritis Among Respiratory Physicians
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tuberculosis is a major infectious disease with a high mortality burden in the Asia-Pacific region and worldwide Among various types of extrapulmonary tuberculosis tuberculous pleuritis TBP is amongst the most common manifestations TBP is also a major underlying cause among patients hospitalised with new-onset unilateral pleural effusion The workup of TBP frequently involves thoracentesis to retrieve pleural fluid and pleural biopsy for microbiological and histological interpretations However the diagnostic accuracy of these tests is of unsatisfactory sensitivity making diagnosing TBP challenging In addition certain tests including pleural fluid adenosine deaminase ADA Mycobacterium tuberculosis polymerase chain reaction MTB PCR advanced biopsy procedures eg real-time image-guided biopsy pleuroscopy are not readily available in developing regions due to scarcity of resources and lack of expertise All these factors lead to heterogeneous practice in approaching new-onset pleural effusion interpretation of pleural TB investigations and timing of TBP treatment initiation among respiratory physicians in different Asia-Pacific regions The proposed multinational survey aims to understand the real-world clinical practice in approaching patients with new-onset unilateral pleural effusion and diagnosing TBP in Asia-Pacific regions with intermediate to high TB burden The results will reflect the current practice of diagnosing TBP clinical and resource discrepancies in investigating TBP management of TBP and help prioritise the need for further research in TBP
Detailed Description:
Tuberculosis TB is one of the major global health threats with an estimated 106 million people infected with TB in 2021 with 16 million dying from the disease Apart from pulmonary involvement as the major manifestation of TB there is an increasing trend of extrapulmonary TB EPTB reported in different continents Among EPTB TB pleuritis TBP was the most prevalent form in several large Chinese retrospective studies
Diagnosing TBP is challenging due to paucibacillary involvement TB disease caused by a small number of bacteria of the pleural space A diagnosis of definite TBP can be secured if the acid-fast bacilli AFB Mycobacterium tuberculosis MTB culture of pleural fluid reveals positive results However these conventional diagnostic tests for TBP are insufficiently sensitive and the long turnaround time of culture would also delay the initial clinical management The diagnosis of definite TBP may also be based on compatible histological findings of the pleural tissue obtained by biopsy procedures bedside biopsy by Abrams needle real-time image-guided biopsy by radiologists or experienced respiratory physicians or pleuroscopy The availability and waiting time of these procedures vary in different regions Due to these reasons a diagnosis of probable TBP may be pursued instead This diagnostic entity is based on compatible clinical presentations with exudative lymphocytic pleural effusion and raised pleural fluid biomarkers commonly adenosine deaminase ADA without diagnostic microbiological results and alternative clinical explanation 10 Other than pleural fluid ADA several pleural fluid biomarkers have been explored to assist in diagnosing probable TBP Therefore a significant proportion of patients suspected to have TBP may have empirical anti-TB treatment initiated in the absence of a confirmatory diagnosis In addition these diagnostic clinical challenges are magnified among Asia-Pacific developing countries where contemporary diagnostic tools may be unavailable and hinder local TB control
There is a lack of regional Asia-Pacific real-world evidence of how TBP is diagnosed and how pleural fluid biomarkers are used We hypothesise that heterogeneous practice towards new-onset unilateral pleural effusion and understanding different diagnostic tests for diagnosing TBP across different countries depends on the TB burden and availability of advanced pleural services Therefore a multinational survey study is designed to understand the real-world practice of managing new-onset unilateral pleural effusion the availability and utilisation of different diagnostic tests for TBP and the factors determining the timing of initiating empirical anti-TB treatment for TBP among respiratory physicians in the Asia-Pacific region
Diagnosing TBP is challenging due to paucibacillary involvement TB disease caused by a small number of bacteria of the pleural space A diagnosis of definite TBP can be secured if the acid-fast bacilli AFB Mycobacterium tuberculosis MTB culture of pleural fluid reveals positive results However these conventional diagnostic tests for TBP are insufficiently sensitive and the long turnaround time of culture would also delay the initial clinical management The diagnosis of definite TBP may also be based on compatible histological findings of the pleural tissue obtained by biopsy procedures bedside biopsy by Abrams needle real-time image-guided biopsy by radiologists or experienced respiratory physicians or pleuroscopy The availability and waiting time of these procedures vary in different regions Due to these reasons a diagnosis of probable TBP may be pursued instead This diagnostic entity is based on compatible clinical presentations with exudative lymphocytic pleural effusion and raised pleural fluid biomarkers commonly adenosine deaminase ADA without diagnostic microbiological results and alternative clinical explanation 10 Other than pleural fluid ADA several pleural fluid biomarkers have been explored to assist in diagnosing probable TBP Therefore a significant proportion of patients suspected to have TBP may have empirical anti-TB treatment initiated in the absence of a confirmatory diagnosis In addition these diagnostic clinical challenges are magnified among Asia-Pacific developing countries where contemporary diagnostic tools may be unavailable and hinder local TB control
There is a lack of regional Asia-Pacific real-world evidence of how TBP is diagnosed and how pleural fluid biomarkers are used We hypothesise that heterogeneous practice towards new-onset unilateral pleural effusion and understanding different diagnostic tests for diagnosing TBP across different countries depends on the TB burden and availability of advanced pleural services Therefore a multinational survey study is designed to understand the real-world practice of managing new-onset unilateral pleural effusion the availability and utilisation of different diagnostic tests for TBP and the factors determining the timing of initiating empirical anti-TB treatment for TBP among respiratory physicians in the Asia-Pacific region
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None