NCT06390969

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 (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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

April 26, 2024

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment decision

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

    1 month

Secondary Outcomes (3)

  • Test availability

    1 month

  • Disease understanding

    1 month

  • Treatment decision for suspected tuberculosis

    1 month

Study Arms (1)

Survey respondent

All respiratory doctors who respond to the survey

Other: Survey

Interventions

SurveyOTHER

Cross-sectional online survey

Survey respondent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Respiratory doctors practising in Asia-Pacific region

You may not qualify if:

  • Do not consent for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pleural EffusionTuberculosis, Pleural

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract Infections

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David SC Hui, MD

    Chinese University of Hong Kong

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2024

First Posted

April 30, 2024

Study Start

July 1, 2024

Primary Completion

November 30, 2024

Study Completion

February 28, 2025

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations