Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
a study on Pleural Infection Bacterial Pleural Infections Pleural Infections and Inflammations Empyema, Pleural Empyema Pleural Effusion
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Diego, California and other locations
- Dates
- study startedstudy ends around
Description
Summary
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.
Official Title
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)
Keywords
Pleural Infection Bacterial, Pleural Infections, Pleural Infections and Inflammations, Empyema, Pleural, Empyema, Complicated Pleural Effusion/ Empyema, Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion, Lytics, Intrapleural enzyme therapy, Once daily, lytic therapy, Inflammation, Pleural Empyema, Fibrinolytic once daily, Fibrinolytic twice daily, DNA degradation once daily, DNA degradation twice daily
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 CAN'T join 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
Locations
- UCSD Hillcrest Medical Center
accepting new patients
San Diego California 92103 United States - Stanford Hospital
accepting new patients
Palo Alto California 94305 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of North Carolina, Chapel Hill
- ID
- NCT07095361
- Phase
- Phase 4 research study
- Study Type
- Interventional
- Participants
- Expecting 270 study participants
- Last Updated
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