Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Recruiting now · Phase 4

Conditions studied: Pleural Infection Bacterial, Pleural Infections, Pleural Infections and Inflammations, Empyema, Pleural, Empyema, Complicated Pleural Effusion/ Empyema, Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion

In brief

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.

Key facts

Study ID

NCT07095361

Run by

University of North Carolina, Chapel Hill

People needed

270

Starts

2025-09-11

Expected to finish

2028-09-30

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 side
• Therapeutic systemic anticoagulation or antiplatelet agents that cannot held for more than 48 hours prior to IET administration
• Expected survival of less than 3 months due to a pathologic condition other than that causing the pleural infection

Where it is running

• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• UNC Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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