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

Intrapleural enzyme therapy (IET) is regarded by recent guidelines as a "rescue" therapy for managing complicated pleural infections; however, it is associated with significant side effects, including pleural bleeding, pain, and fever. Pleural irrigation with saline may serve as an alternative, yet evidence supporting its effectiveness is limited to a single small- scale, single-center randomized trial. The objective of the study is to compare the risk of treatment failure at 30 days (defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy) between an early pleural irrigation strategy and standard care for complicated pleural infections.

NCT Number	NCT07666464
Lead Sponsor	Centre Hospitalier Universitaire, Amiens Collaborators: University Hospital, Toulouse, Central Hospital Saint Quentin, CRC CHI Creteil France, University Hospital, Tours, Centre Hospitalier Universitaire de Nīmes, University Hospital, Brest, CH Morlaix, University Hospital, Caen, University Hospital, Rouen, University Hospital, Angers, Hospices Civils de Lyon, CH Pontoise, CH Avignon, Centre Hospitalier VALENCIENNES, CH Le Havre, Tenon Hospital, Paris, University Hospital, Bordeaux, Centre Hospitalier Argenteuil, University Hospital, Strasbourg, France, Nantes University Hospital, CH Haguenau, CHU de Reims, Centre Hospitalier Alpes Leman, Central Hospital, Nancy, France
Conditions	Therapy, Pleural Infections
Enrollment	244 participants
Start Date	2026-05-13
Primary Completion	2029-05 (estimated)
Study Completion	2029-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-01