RECRUITING Phase 4 ClinicalTrials.gov

Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Sponsor: University of North Carolina, Chapel Hill • ClinicalTrials.gov ID: NCT07095361

Registry updated: 2026-09-29

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Description

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.

Interventions

Fibrinolytic once daily (Drug)
tissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.
Fibrinolytic twice daily (Drug)
tissue plasminogen activator (tPA) 10mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.
DNA degradation once daily (Drug)
Deoxyribonuclease (DNase) 5mg will be administered once a day as intrapleural enzyme therapy (IET) for 3 consecutive days.
DNA degradation twice daily (Drug)
Deoxyribonuclease (DNase) 5mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.

Eligibility criteria

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

Conditions

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

Locations

University of Arkansas Medical Center — Little Rock, Arkansas, United States
Stanford Hospital — Palo Alto, California, United States
UCSD Hillcrest Medical Center — San Diego, California, United States
Yale New Haven Hospital — New Haven, Connecticut, United States
Northwestern University — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
Henry Ford Hospital — Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
NYU Langone Health — New York, New York, United States
UNC Chapel Hill — Chapel Hill, North Carolina, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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