Tuberculous Pleural EffusionFIB-TBNCT07823075
Efficacy and Safety of Intrapleural Fibrinolytic Therapy in Tuberculous Pleural Effusion Versus Non-Tuberculous Pleural Infection
An observational study of Tuberculous Pleural Effusion, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tuberculous Pleural Effusion
- What is being tested?
- Intrapleural Fibrinolytic Therapy (IPFT)
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Sep 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged ≥18 years.
- Patients with tuberculous pleural effusion or non-tuberculous pleural effusion diagnosed based on clinical, radiological, laboratory, microbiological, histopathological, and/or pleuroscopic findings.
- Patients who received intrapleural fibrinolytic therapy with tissue plasminogen activator and deoxyribonuclease during the study period.
Who cannot join
- Malignant and transudative pleural effusion
- Patients who received intrapleural fibrinolytic therapy as monotherapy with either tissue plasminogen activator or deoxyribonuclease alone.
- Incomplete medical records
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
National University of Malaysia
Kuala Lumpur, Kuala Lumpur, 56000
About this study
Official title: Efficacy and Safety of Intrapleural Fibrinolytic Therapy in Tuberculous Pleural Effusion Versus Non-Tuberculous Pleural Infection: A Ten-Year Retrospective Study at Hospital Canselor Tuanku Muhriz (FIB-TB Study)
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.
Read the detailed description
- This is a single-centre retrospective cohort study conducted at HCTM, Malaysia.
- Medical records of adult patients (≥18 years) who received intrapleural fibrinolytic therapy (IPFT) between 1 January 2016 and 31 December 2025 will be reviewed.
- Eligible patients who received combined intrapleural tissue plasminogen activator and deoxyribonuclease therapy will be identified according to the predefined inclusion and exclusion criteria.
- Patients will be categorized into two cohorts based on the underlying diagnosis:
- Tuberculous pleural effusion (TPE)
- Non-tuberculous pleural effusion (Non-TPE)
- Demographic data, comorbidities, clinical presentation, laboratory and pleural fluid findings, microbiological results, imaging findings, IPFT regimen, and treatment outcomes will be extracted from electronic medical records using a standardized data collection form.
- The primary outcome will be radiological improvement, assessed by the percentage reduction in pleural opacity on chest radiographs before and after IPFT.
- Secondary outcomes will include clinical symptom improvement, pleural fluid drainage volume, changes in inflammatory markers, requirement for additional pleural interventions or surgery, and treatment-related adverse events, including bleeding, chest pain requiring analgesia, and secondary pleural infection.
- Baseline characteristics and clinical outcomes will be compared between the TPE and NTPI cohorts using appropriate descriptive and inferential statistical analyses. Multivariable regression analysis will be performed to identify factors associated with treatment outcomes and to adjust for potential confounding variables where appropriate.
- Conditions
- Tuberculous Pleural Effusion
- Being tested
- Intrapleural Fibrinolytic Therapy (IPFT)
- Keywords
- Tuberculous Pleural Effusion, Non-Tuberculous Pleural Infection, Intrapleural Fibrinolytic Therapy, Tissue Plasminogen Activator, Alteplase, DNase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapleural Fibrinolytic Therapy (IPFT)Procedure or surgery
Also called Alteplase (tissue plasminogen activator, tPA), Dornase alfa (DNase)
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.
| Study group | Role | What they receive |
|---|---|---|
| Non- Tuberculous Pleural Effusion | Non-TPE: Patients with pleural infection who had no microbiological or histological evidence of MTB and/or for whom an alternative diagnosis was established. Receives: Procedure: Intrapleural Fibrinolytic Therapy (IPFT) | |
| Tuberculous Pleural effusion | 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. Receives: Procedure: Intrapleural Fibrinolytic Therapy (IPFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (before initiation of IPFT) to Day 7-10 after initiation of IPFT
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: From initiation of IPFT until hospital discharge or within 30 days after IPFT initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Tuberculous Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MOHAMED FAISAL ABDUL HAMID, MBBS, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823075
- Sponsor's protocol ID
- FF-2026-296
- Acronym
- FIB-TB
- Status last verified
- Sep 2026
- First submitted
- 2 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colares PFB, Rivas JKD, Sciortino ADS, Sales RKB, Teixeira LR. Tuberculous empyema: combined intrapleural therapy might be an alternative. J Bras Pneumol. 2022 Nov 28;48(6):e20220232. doi: 10.36416/1806-3756/e20220232. No abstract available.
PubMed 36449818Zhai K, Lu Y, Shi HZ. Tuberculous pleural effusion. J Thorac Dis. 2016 Jul;8(7):E486-94. doi: 10.21037/jtd.2016.05.87.
PubMed 27499981Abdul Hamid MF, Hasbullah AHH, Mohamad Jailaini MF, Nik Abeed NN, Ng BH, Haron H, Md Ali NA, Ismail MI, Nik Ismail NA, Abdul Rahman MR, Ban AY. Retrospective review comparing intrapleural fibrinolytic therapy (alteplase) and surgical intervention in complex pleural effusion. BMC Pulm Med. 2022 Nov 23;22(1):439. doi: 10.1186/s12890-022-02239-w.
PubMed 36419155Yong GKW, Wong JJJ, Zhang X, Tan CPS, Wang XN, Quek PS, Yap KH. Intrapleural fibrinolytic therapy for pleural infections: Outcomes from a cohort study. Ann Acad Med Singap. 2024 Dec 12;53(12):724-733. doi: 10.47102/annals-acadmedsg.2024276.
PubMed 39748171McNally E, Ross C, Gleeson LE. The tuberculous pleural effusion. Breathe (Sheff). 2023 Dec;19(4):230143. doi: 10.1183/20734735.0143-2023. Epub 2023 Dec 19.
PubMed 38125799Bian Y, Deng M, Zhang Q, Hou G. Global trends of research on tuberculous pleurisy over the past 15 years: A bibliometric analysis. Front Cell Infect Microbiol. 2022 Aug 30;12:937811. doi: 10.3389/fcimb.2022.937811. eCollection 2022.
PubMed 36111237Chiner E, Nomdedeu M, Vanes S, Pastor E, Esteban V, Castello C, Boira I, Molina V, Arriero JM, Sancho-Chust JN. Clinical and Epidemiological Features of Tuberculous Pleural Effusion in Alicante, Spain. J Clin Med. 2021 Sep 26;10(19):4392. doi: 10.3390/jcm10194392.
PubMed 34640410Lo Cascio CM, Kaul V, Dhooria S, Agrawal A, Chaddha U. Diagnosis of tuberculous pleural effusions: A review. Respir Med. 2021 Nov;188:106607. doi: 10.1016/j.rmed.2021.106607. Epub 2021 Sep 6.
PubMed 34536698Shien TK, Mohamad Jailaini MF, Azmel AA, Munusamy V, Alaga A, Abdul Hamid MF. Diagnostic utility of pleural fluid adenosine deaminase in tuberculous pleural effusion in patients with exudative effusion: a retrospective multicenter study (ADATPE). J Thorac Dis. 2026 Mar 31;18(3):216. doi: 10.21037/jtd-2026-1-0015. Epub 2026 Feb 27.
PubMed 41988261Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.
PubMed 21830966Cheong XK, Abdul Hamid MF. Intrapleural alteplase and DNase for complex tuberculous pleurisy: a medical approach. Respirol Case Rep. 2021 Jan 3;9(2):e00706. doi: 10.1002/rcr2.706. eCollection 2021 Feb.
PubMed 33425359Luengo-Fernandez R, Penz E, Dobson M, Psallidas I, Nunn AJ, Maskell NA, Rahman NM. Cost-effectiveness of intrapleural use of tissue plasminogen activator and DNase in pleural infection: evidence from the MIST2 randomised controlled trial. Eur Respir J. 2019 Aug 1;54(2):1801550. doi: 10.1183/13993003.01550-2018. Print 2019 Aug.
PubMed 31097519Piccolo F, Popowicz N, Wong D, Lee YC. Intrapleural tissue plasminogen activator and deoxyribonuclease therapy for pleural infection. J Thorac Dis. 2015 Jun;7(6):999-1008. doi: 10.3978/j.issn.2072-1439.2015.01.30.
PubMed 26150913
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intrapleural Fibrinolytic Therapy in Tuberculous Pleural Effusion Versus Non-Tuberculous Pleural Infection: A Ten-Year Retrospective Study at Hospital Canselor Tuanku Muhriz (FIB-TB Study)
- ClinicalTrials.gov ID
- NCT07823075
- Acronym / sponsor ID
- FIB-TB / FF-2026-296
- Conditions
- Tuberculous Pleural Effusion
- Keywords
- Tuberculous Pleural Effusion, Non-Tuberculous Pleural Infection, Intrapleural Fibrinolytic Therapy, Tissue Plasminogen Activator, Alteplase, DNase
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- This is a single-centre retrospective cohort study conducted at HCTM, Malaysia.
- Medical records of adult patients (≥18 years) who received intrapleural fibrinolytic therapy (IPFT) between 1 January 2016 and 31 December 2025 will be reviewed.
- Eligible patients who received combined intrapleural tissue plasminogen activator and deoxyribonuclease therapy will be identified according to the predefined inclusion and exclusion criteria.
- Patients will be categorized into two cohorts based on the underlying diagnosis:
- Tuberculous pleural effusion (TPE)
- Non-tuberculous pleural effusion (Non-TPE)
- Demographic data, comorbidities, clinical presentation, laboratory and pleural fluid findings, microbiological results, imaging findings, IPFT regimen, and treatment outcomes will be extracted from electronic medical records using a standardized data collection form.
- The primary outcome will be radiological improvement, assessed by the percentage reduction in pleural opacity on chest radiographs before and after IPFT.
- Secondary outcomes will include clinical symptom improvement, pleural fluid drainage volume, changes in inflammatory markers, requirement for additional pleural interventions or surgery, and treatment-related adverse events, including bleeding, chest pain requiring analgesia, and secondary pleural infection.
- Baseline characteristics and clinical outcomes will be compared between the TPE and NTPI cohorts using appropriate descriptive and inferential statistical analyses. Multivariable regression analysis will be performed to identify factors associated with treatment outcomes and to adjust for potential confounding variables where appropriate.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non- Tuberculous Pleural Effusion | – | Procedure: Intrapleural Fibrinolytic Therapy (IPFT)Non-TPE: Patients with pleural infection who had no microbiological or histological evidence of MTB and/or for whom an alternative diagnosis was established. |
| Tuberculous Pleural effusion | – | 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Adults aged ≥18 years.
- Patients with tuberculous pleural effusion or non-tuberculous pleural effusion diagnosed based on clinical, radiological, laboratory, microbiological, histopathological, and/or pleuroscopic findings.
- Patients who received intrapleural fibrinolytic therapy with tissue plasminogen activator and deoxyribonuclease during the study period.
Key exclusion criteria (3 listed)
- Malignant and transudative pleural effusion
- Patients who received intrapleural fibrinolytic therapy as monotherapy with either tissue plasminogen activator or deoxyribonuclease alone.
- Incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrapleural Fibrinolytic Therapy (IPFT)Also: Alteplase (tissue plasminogen activator, tPA), Dornase alfa (DNase)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. | Procedure or surgery | Non- Tuberculous Pleural Effusion, Tuberculous Pleural effusion |
Primary outcome
Percentage reduction in pleural opacity area on chest radiograph following IPFT
Time frame: Day 0 (before initiation of IPFT) to Day 7-10 after initiation of 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.
3 secondary outcomes
Clinical characteristics of participants with TPE and non-TPE
Time frame: From diagnosis until completion of the index hospital admission
Clinical treatment success following IPFT
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
Time frame: From initiation of IPFT until hospital discharge or within 30 days after IPFT initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 36449818Colares PFB, Rivas JKD, Sciortino ADS, Sales RKB, Teixeira LR. Tuberculous empyema: combined intrapleural therapy might be an alternative. J Bras Pneumol. 2022 Nov 28;48(6):e20220232. doi: 10.36416/1806-3756/e20220232. No abstract available.
- Results publication: PubMed 27499981Zhai K, Lu Y, Shi HZ. Tuberculous pleural effusion. J Thorac Dis. 2016 Jul;8(7):E486-94. doi: 10.21037/jtd.2016.05.87.
- Results publication: PubMed 36419155Abdul Hamid MF, Hasbullah AHH, Mohamad Jailaini MF, Nik Abeed NN, Ng BH, Haron H, Md Ali NA, Ismail MI, Nik Ismail NA, Abdul Rahman MR, Ban AY. Retrospective review comparing intrapleural fibrinolytic therapy (alteplase) and surgical intervention in complex pleural effusion. BMC Pulm Med. 2022 Nov 23;22(1):439. doi: 10.1186/s12890-022-02239-w.
- Results publication: PubMed 39748171Yong GKW, Wong JJJ, Zhang X, Tan CPS, Wang XN, Quek PS, Yap KH. Intrapleural fibrinolytic therapy for pleural infections: Outcomes from a cohort study. Ann Acad Med Singap. 2024 Dec 12;53(12):724-733. doi: 10.47102/annals-acadmedsg.2024276.
- Results publication: PubMed 38125799McNally E, Ross C, Gleeson LE. The tuberculous pleural effusion. Breathe (Sheff). 2023 Dec;19(4):230143. doi: 10.1183/20734735.0143-2023. Epub 2023 Dec 19.
- Results publication: PubMed 36111237Bian Y, Deng M, Zhang Q, Hou G. Global trends of research on tuberculous pleurisy over the past 15 years: A bibliometric analysis. Front Cell Infect Microbiol. 2022 Aug 30;12:937811. doi: 10.3389/fcimb.2022.937811. eCollection 2022.
- Results publication: PubMed 34640410Chiner E, Nomdedeu M, Vanes S, Pastor E, Esteban V, Castello C, Boira I, Molina V, Arriero JM, Sancho-Chust JN. Clinical and Epidemiological Features of Tuberculous Pleural Effusion in Alicante, Spain. J Clin Med. 2021 Sep 26;10(19):4392. doi: 10.3390/jcm10194392.
- Results publication: PubMed 34536698Lo Cascio CM, Kaul V, Dhooria S, Agrawal A, Chaddha U. Diagnosis of tuberculous pleural effusions: A review. Respir Med. 2021 Nov;188:106607. doi: 10.1016/j.rmed.2021.106607. Epub 2021 Sep 6.
- Results publication: PubMed 41988261Shien TK, Mohamad Jailaini MF, Azmel AA, Munusamy V, Alaga A, Abdul Hamid MF. Diagnostic utility of pleural fluid adenosine deaminase in tuberculous pleural effusion in patients with exudative effusion: a retrospective multicenter study (ADATPE). J Thorac Dis. 2026 Mar 31;18(3):216. doi: 10.21037/jtd-2026-1-0015. Epub 2026 Feb 27.
- Results publication: PubMed 21830966Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.
- Results publication: PubMed 33425359Cheong XK, Abdul Hamid MF. Intrapleural alteplase and DNase for complex tuberculous pleurisy: a medical approach. Respirol Case Rep. 2021 Jan 3;9(2):e00706. doi: 10.1002/rcr2.706. eCollection 2021 Feb.
- Results publication: PubMed 31097519Luengo-Fernandez R, Penz E, Dobson M, Psallidas I, Nunn AJ, Maskell NA, Rahman NM. Cost-effectiveness of intrapleural use of tissue plasminogen activator and DNase in pleural infection: evidence from the MIST2 randomised controlled trial. Eur Respir J. 2019 Aug 1;54(2):1801550. doi: 10.1183/13993003.01550-2018. Print 2019 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MOHAMED FAISAL ABDUL HAMID, MBBS principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculous Pleural Effusion, run by National University of Malaysia at 1 site in Malaysia.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 16 Sep 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Faisal Abdul Hamid, MBBS (60391455555, faisal.hamid@hctm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in pleural opacity area on chest radiograph following IPFT (time frame: Day 0 (before initiation of IPFT) to Day 7-10 after initiation of IPFT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823075, which also lists 13 linked publications.
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 16 Sep 2026.