Clinical Trial

Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Study acronym: ONLY ONCE
Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
notable Trial sites expanded: 2 -> 6 locations 2026-05-20
Trial Details
NCT Number NCT07095361
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Northwestern Memorial Hospital, Henry Ford Health System, Yale University, Rush University Medical Center, Dartmouth-Hitchcock Medical Center
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
Enrollment 270 participants
Start Date 2025-09-11
Primary Completion 2028-09-30 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-19