Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management (NCT04915586) | Clinical Trial Compass
CompletedNot Applicable
Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management
Malaysia30 participantsStarted 2019-12-30
Plain-language summary
The aim of this study was to assess the efficacy of the modified regimen short duration intrapleural 16mg alteplase (Actilyse, Boehringer Ingelheim) with 5mg DNase (Pulmozyme Hoffmann-La Roche Ltd) in patients with pleural infection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adult patient with age more than 17 year old
* evidence of complex parapneumonic effusion or empyema; with poor pleural fluid drainage of ≤150 mL after 24 hours of insertion of chest drain
* clinical evidence of infection such as fever and or elevated C-reactive protein (CRP) or white-cell count
* complex pleural effusion proven by ultrasound
* pleural fluid analysis that fulfilled at least one of the characteristics: frank pus, exudative nature (according to light's criteria), gram stain or culture positive, lactate dehydrogenase (LDH) \> 1000 U/L, pH \< 7.2 and/or glucose level \< 3.3mmol/L
Exclusion Criteria:
* known allergy to pulmozyme or alteplase
* acute stroke, active bleeding diathesis
* major surgery in past 5 days
* previous pneumonectomy on the infected side
* bronchopleural fistula
* pregnancy
* coagulopathy (INR \> 2, APTT \>100, platelet count \< 50,000 cells)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiographic improvement in pleural opacity on chest radiograph