[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656139":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":41,"overallOfficials":50,"centralContacts":54,"locations":63,"responsibleParty":75,"collaborators":26,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":26,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":101,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"National University of Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Day 0 (before initiation of IPFT) to Day 7-10 after initiation of IPFT",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"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.","From diagnosis until completion of the index hospital admission",{"measure":19,"description":20,"timeFrame":21},"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","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",{"measure":23,"description":24,"timeFrame":25},"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.","From initiation of IPFT until hospital discharge or within 30 days after IPFT initiation",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":6,"timePerspective":28,"maskingInfo":26},"RETROSPECTIVE","1. This is a single-centre retrospective cohort study conducted at HCTM, Malaysia.\n2. Medical records of adult patients (≥18 years) who received intrapleural fibrinolytic therapy (IPFT) between 1 January 2016 and 31 December 2025 will be reviewed.\n3. Eligible patients who received combined intrapleural tissue plasminogen activator and deoxyribonuclease therapy will be identified according to the predefined inclusion and exclusion criteria.\n4. Patients will be categorized into two cohorts based on the underlying diagnosis:\n\n   * Tuberculous pleural effusion (TPE)\n   * Non-tuberculous pleural effusion (Non-TPE)\n5. 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.\n6. The primary outcome will be radiological improvement, assessed by the percentage reduction in pleural opacity on chest radiographs before and after IPFT.\n7. 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.\n8. 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.","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.",[32,37],{"label":33,"type":26,"description":34,"interventionNames":35},"Non- Tuberculous Pleural Effusion","Non-TPE: Patients with pleural infection who had no microbiological or histological evidence of MTB and\u002For for whom an alternative diagnosis was established.",[36],"Procedure: Intrapleural Fibrinolytic Therapy (IPFT)",{"label":38,"type":26,"description":39,"interventionNames":40},"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\u002For histopathological evidence of caseating granulomatous inflammation consistent with TB on pleural biopsy.\n\nOR\n\nClinical TPE - Patients without microbiological or histopathological confirmation but diagnosed by a respiratory physician based on clinical, radiological, biochemical, and\u002For pleuroscopic findings. Diagnosis requires at least two supportive criteria: compatible TB symptoms, radiological features suggestive of pleural TB, pleural fluid ADA \\>40 U\u002FL, pleuroscopy findings suggestive of tuberculous pleuritis (e.g., pleural nodularity, inflammation, thickening, adhesions, or granulomatous changes), and\u002For clinical or radiological improvement following empirical anti-tuberculosis therapy.",[36],[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"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.",[33,38],[48,49],"Alteplase (tissue plasminogen activator, tPA)","Dornase alfa (DNase)",[51],{"name":52,"affiliation":5,"role":53},"MOHAMED FAISAL ABDUL HAMID, MBBS","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":26,"email":59},"Mohamed Faisal Abdul Hamid, MBBS","CONTACT","60391455555","faisal.hamid@hctm.ukm.edu.my",{"name":61,"role":57,"phone":58,"phoneExt":26,"email":62},"VINOD RAJ MANIKAM, MD","veenod18@gmail.com",[64],{"facility":5,"status":26,"city":65,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":26},"Kuala Lumpur","56000","Malaysia","MY",{"type":70,"coordinates":71},"Point",[72,73],101.68653,3.1412,{"lat":73,"lon":72},{"type":76,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100656139","efficacy-and-safety-of-intrapleural-fibrinolytic-therapy-in-tuberculous-pleural-effusion-versus-non-tuberculous-pleural-infection-100656139",false,"NCT07823075","Efficacy and Safety of Intrapleural Fibrinolytic Therapy in Tuberculous Pleural Effusion Versus Non-Tuberculous Pleural Infection","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)","FIB-TB","Inclusion Criteria:\n\n1. Adults aged ≥18 years.\n2. Patients with tuberculous pleural effusion or non-tuberculous pleural effusion diagnosed based on clinical, radiological, laboratory, microbiological, histopathological, and\u002For pleuroscopic findings.\n3. Patients who received intrapleural fibrinolytic therapy with tissue plasminogen activator and deoxyribonuclease during the study period.\n\nExclusion Criteria:\n\n1. Malignant and transudative pleural effusion\n2. Patients who received intrapleural fibrinolytic therapy as monotherapy with either tissue plasminogen activator or deoxyribonuclease alone.\n3. Incomplete medical records","ALL","18 Years","85 Years",{"count":89,"type":90},160,"ESTIMATED","OBSERVATIONAL","This retrospective cohort study evaluates the efficacy and safety of intrapleural fibrinolytic therapy (tPA\u002FDNase) 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.",[94],"Tuberculous Pleural Effusion",[94,96,97,98,99,100],"Non-Tuberculous Pleural Infection","Intrapleural Fibrinolytic Therapy","Tissue Plasminogen Activator","Alteplase","DNase","NOT_YET_RECRUITING","2026-09-10",{"date":104,"type":105},"2026-09-16","ACTUAL",{"date":107,"type":90},"2026-09-20",{"date":109,"type":90},"2027-06-01",{"name":5,"class":6},1]