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Pleural EffusionNCT06390969

TBP Survey Among Respiratory Physicians

An observational study of Pleural Effusion and Tuberculosis, Pleural, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pleural Effusion, Tuberculosis, Pleural
What is being tested?
Survey
How many people
418 participants
Where
1 siteHong Kong
Study dates
1 Jul 2024to 28 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The questionnaire will be sent via social media, including WhatsApp, Facebook, X (formerly known as Twitter), targeting respiratory physicians practising in various Asia-Pacific regions, especially regions with intermediate to high TB burden, through snowball sampling. These regions include China, Hong Kong, India, Malaysia, Philippines, Singapore, Taiwan (based on the network of the applicants) and beyond.

Who may be able to join

  • Respiratory doctors practising in Asia-Pacific region

Who cannot join

  • Do not consent for the study

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Survey on the Practice and Interpretation of Various Diagnostic Tests for Tuberculous Pleuritis Among Respiratory Physicians

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 (e.g. 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

Read the detailed description

Tuberculosis (TB) is one of the major global health threats, with an estimated 10.6 million people infected with TB in 2021, with 1.6 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 Abram's 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.

Being tested
Survey
Medical subject headings
Pleural Effusion, Tuberculosis, Pleural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyOther

    Cross-sectional online survey

Study groups in NCT06390969
Study groupRoleWhat they receive
Survey respondentAll respiratory doctors who respond to the survey
Receives: Other: Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment decision

    the proprtion of respondents that would consider TBP as one of the differential diagnoses when approaching new-onset unilateral pleural effusion

    Measured: 1 month

Secondary outcomes (3)
  1. Test availability

    To evaluate the availability of different diagnostic tests for diagnosing TBP, in 5 point Likert scale

    Measured: 1 month

  2. Disease understanding

    To evaluate the understanding and utilisation of pleural fluid biomarkers for TBP among respiratory physicians, in 5 point Likert scale

    Measured: 1 month

  3. Treatment decision for suspected tuberculosis

    To evaluate the factors determining the initiation of empirical anti-TB treatment for probable TBP, in 5 point Likert scale

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start1 Jul 2024
  3. Primary completion30 Nov 2024
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06390969
Sponsor's protocol ID
TBP_survey
Status last verified
Mar 2026
First submitted
26 Apr 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pleural Effusion and Tuberculosis, Pleural, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment decision (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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