NCT07095361 Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
| NCT ID | NCT07095361 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Pleural Infection Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 270 participants in total. It began in 2025-09-11 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Jason Akulian, MD, MPH
PRINCIPAL INVESTIGATOR
University of North Carollina at Chapel Hill
Frequently Asked Questions
Who can join the NCT07095361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Infection Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07095361 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07095361 currently recruiting?
Yes, NCT07095361 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of North Carolina, Chapel Hill to inquire about joining.
Where is the NCT07095361 trial being conducted?
This trial is being conducted at New Haven, United States, Chicago, United States, Chicago, United States, Detroit, United States and 2 additional locations.
Who is sponsoring the NCT07095361 clinical trial?
NCT07095361 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Jason Akulian, MD, MPH at University of North Carollina at Chapel Hill. The trial plans to enroll 270 participants.