Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (NCT07095361) | Clinical Trial Compass
RecruitingPhase 4
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
United States270 participantsStarted 2025-09-11
Plain-language summary
The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection.
The investigators are trying to learn:
* Does using the medicine once a day work just as well as using it twice a day?
* Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?
* Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?
Participants will:
* Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung.
* Be asked to give permission to join the study.
* Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.
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:
* Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA authorization for release of personal health information.
* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
* Age ≥ 18 years at the time of consent.
* Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of IET
* Pleural fluid that is one of the following:
(i) Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential of hydrogen (pH) \< 7.2 (iii) Pleural fluid glucose \< 60mg/dL (iv) Pleural fluid Lactate Dehydrogenase (LDH) \> 1,000 IU/L
* Patient is deemed a candidate to receive intrapleural enzyme therapy as defined by having a residual collection or persistent sepsis 24 hours after initial chest tube placement
Exclusion Criteria:
* Known pregnancy or lactating females
* Prisoners
* Age \<18 years at time of consent
* Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission
* Known sensitivity or allergic reaction to DNAse or tPA
* Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days
* Previous pneumonectomy or active bronchopleural fistula on the affected …
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.