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

Study acronym: EPISSOC
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Interventions: Standard care (Procedure), intrapleural irrigation (Procedure) to Standard care (Procedure), intrapleural irrigation (Drug)
    • Study title shortened, about 3 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Therapy, Pleural Infections
Enrollment 244 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov