An observational study in Tuberculous Pleural Effusion, sponsored by National University of Malaysia. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by National University of Malaysia · Observational
This retrospective cohort study evaluates the efficacy and safety of intrapleural fibrinolytic therapy (tPA/DNase) in patients with tuberculous pleural effusion compared with non-tuberculous pleural infection at Hospital Canselor Tuanku Muhriz (HCTM), Malaysia. The study aims to compare radiological improvement, clinical outcomes, and treatment-related adverse events to provide evidence supporting the use of IPFT in tuberculous pleural effusion.
Patients will be categorized into two cohorts based on the underlying diagnosis:
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 160 is above the median of 140 across 93 observational studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
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All adult patients diagnosed with tuberculous pleural effusion and non-tuberculous pleural effusion who received IPFT using tissue plasminogen activator and deoxyribonuclease, during the study period. Relevant data will be extracted from patients' case notes or electronic medical records.
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Exclusion Criteria:
Non-TPE: Patients with pleural infection who had no microbiological or histological evidence of MTB and/or for whom an alternative diagnosis was established.
Procedure: Intrapleural Fibrinolytic Therapy (IPFT)
Definite TPE - Patients with microbiologically confirmed TB from pleural fluid or pleural biopsy specimens (positive MTB culture, AFB smear, or Xpert MTB), and/or histopathological evidence of caseating granulomatous inflammation consistent with TB on pleural biopsy. OR Clinical TPE - Patients without microbiological or histopathological confirmation but diagnosed by a respiratory physician based on clinical, radiological, biochemical, and/or pleuroscopic findings. Diagnosis requires at least two supportive criteria: compatible TB symptoms, radiological features suggestive of pleural TB, pleural fluid ADA \>40 U/L, pleuroscopy findings suggestive of tuberculous pleuritis (e.g., pleural nodularity, inflammation, thickening, adhesions, or granulomatous changes), and/or clinical or radiological improvement following empirical anti-tuberculosis therapy.
Procedure: Intrapleural Fibrinolytic Therapy (IPFT)
Patients received intrapleural fibrinolytic therapy with alteplase and DNase through an intercostal chest tube for management of complicated pleural infection. Clinical outcomes following IPFT were compared between patients with tuberculous pleural effusion and non-tuberculous pleural effusion.
Also known as: Alteplase (tissue plasminogen activator, tPA), Dornase alfa (DNase)
Percentage reduction in pleural opacity area on chest radiograph following IPFT
Radiological response to IPFT will be assessed by measuring the percentage reduction in pleural opacity area on chest radiographs from baseline (Day 0, prior to IPFT initiation) to the follow-up radiograph performed between Day 7-10 after IPFT initiation or the earliest available follow-up radiograph, whichever occurs earlier. Pleural opacity area will be measured using Horos software version 3.3.2.
Time frame: Day 0 (before initiation of IPFT) to Day 7-10 after initiation of IPFT
Clinical characteristics of participants with TPE and non-TPE
The number of participants with each prespecified categorical clinical characteristic-including presenting symptoms, comorbidities, positive microbiological findings, radiological findings and treatment-related characteristics-will be reported separately for the TPE and non-TPE groups, unit of measurement: Number of participants.
Time frame: From diagnosis until completion of the index hospital admission
Clinical treatment success following IPFT
Clinical treatment success will be defined as successful management of the pleural effusion without the need for video-assisted thoracoscopic surgery or surgical decortication within 30 days after the first IPFT dose. The proportion of participants achieving treatment success will be compared between the TPE and non-TPE groups. Unit of measurement : Percentage of participants
Time frame: Day 0 (before IPFT initiation) to Day 7-10 after IPFT initiation or until hospital discharge, with surgical intervention assessed within 30 days after IPFT initiation
Treatment-related adverse events following IPFT in patients with TPE
Treatment-related adverse events associated with IPFT in patients with TPE will be assessed, including chest pain requiring analgesic treatment, pleural bleeding or haemothorax, and secondary pleural infection or empyema attributable to IPFT. Adverse events will be identified from clinical documentation, laboratory results, imaging findings, and treatment records following IPFT administration.
Time frame: From initiation of IPFT until hospital discharge or within 30 days after IPFT initiation
Plan to share: No
Start is estimated for Sep 2026; primary completion for May 2027, 7 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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