Phase 3 Study Comparing Early Pleural Irrigation With Saline to Standard Care for Adults With Complicated Pleural Infections

What this Trial Is About

Researchers are evaluating a new approach for treating complicated pleural infections, which occur when infection causes fluid buildup in the space around the lungs. Currently, intrapleural enzyme therapy is used as a rescue treatment but can cause significant side effects like bleeding, pain, and fever. This trial aims to compare the risk of treatment failure within 30 days between an early pleural irrigation strategy using saline and the standard care approach. Participants will be randomly assigned to one of two groups. The experimental group will receive 500 mL saline irrigations into the chest cavity via a chest tube twice daily for a total of six irrigations, followed by suction drainage. The control group will receive standard care, which includes pleural drainage with smaller saline flushes 20 mL twice daily for 3 days to keep the chest tube open, plus suction drainage. Both groups will be monitored for treatment outcomes and side effects. During the study, participants will have assessments to measure treatment success, fluid drainage volumes, complications, need for additional surgery or enzyme therapy, hospital stay length, lung function, pain levels, and imaging changes. Safety will be monitored for up to 90 days. The main outcome measured is the rate of treatment failure at 30 days, defined by death, surgery, or need for further enzyme therapy. Participants will be followed for several months to evaluate longer-term effects and recovery.

Comparison of Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.