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Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)

Who can join

Ages 18 and older · All sexes

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 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

About the study

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.

What is being tested

• Fibrinolytic once daily (drug)
• Fibrinolytic twice daily (drug)
• DNA degradation once daily (drug)
• DNA degradation twice daily (drug)

Sponsor: University of North Carolina, Chapel Hill · Participants: 270 · Started: Sep 11, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07095361

Locations in the U.S.

Conditions

• Pleural Effusion

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.