NCT07095361 · University of North Carolina, Chapel Hill
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
(ONLY ONCE)
What this study 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- New Haven, Connecticut
- Chicago, Illinois
- Detroit, Michigan
- Lebanon, New Hampshire
- Chapel Hill, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations