Actively Recruiting
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-06
270
Participants Needed
2
Research Sites
159 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
N
Northwestern Memorial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from the patient or their legally authorized representative
- Willingness and ability to follow study procedures
- Age 18 years or older at time of consent
- Hospitalized with a pleural effusion drained by a chest tube suitable for intrapleural enzyme therapy
- Pleural fluid that is purulent, or positive for bacteria, or has pH less than 7.2, or glucose below 60 mg/dL, or LDH above 1000 IU/L
- Candidate for intrapleural enzyme therapy due to residual fluid or ongoing infection 24 hours after chest tube placement
You will not qualify if you...
- Known pregnancy or breastfeeding
- Prisoners
- Age under 18 years at time of consent
- Previous treatment with intrapleural fibrinolytics or DNase during this hospital admission
- Known allergy to DNase or tPA
- Recent stroke, major bleeding needing blood transfusion within 5 days, major trauma, or major surgery within 5 days
- Previous lung removal surgery or active bronchopleural fistula on affected side
- Use of systemic anticoagulants or antiplatelet drugs that cannot be stopped for over 48 hours before therapy
- Expected survival less than 3 months from other conditions besides pleural infection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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