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NCT07666464
Comparison of Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.
Conditions: Therapy, Pleural Infections
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 244
Sponsor: Centre Hospitalier Universitaire, Amiens
Location: CHU Amiens Picardie Amiens Picardie
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Adults (≥18 years old) capable of fully understanding the study;
* Complicated pleural infection (macroscopically purulent fluid, positive for bacteria on Gram's staining, positive on culture for bacterial infection, loculated effusion, pH \
Source: ClinicalTrials.gov (NCT07666464). StuddyBuddy aggregates publicly available trial information.