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

NCT07666464

RecruitingPhase 3

Sponsor: Centre Hospitalier Universitaire, Amiens

Conditions: Therapy, Pleural Infections

Interventions: intrapleural irrigation, Standard care

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<7.2, great abundance) leading to thoracic drainage;
* Initial ultrasound evaluation to estimate pleural fluid abundance and detect fibrinous septation;
* Social security affiliation
* Written informed consent
* Highly effective contraceptive methods for women of childbearing age include: Combined hormonal contraception (estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; hormone- releasing intrauterine system; bilateral occlusion of the Fallopian tubes; vasectomized partner; sexual abstinence

Exclusion Criteria:

* Tuberculous pleural effusions;
* Previous treatment with intrapleural fibrinolytic agents (urokinase, streptokinase, alteplase, or DNase) or intrapleural saline lavage;
* Previous thoracic surgery for pleural infection;
* Contraindications to auxiliary treatments, to fibrinolysis or surgery as well as to procedures such as drainage and lavage;
* Pregnancy or lactation;
* Expected survival of less than 3 months;
* Thoracic drainage since more than 24h;
* Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision);
* Inability to give informed written consent;
* Participation in another clinical trial;
* Patient being a relative of the investigator or any member of the team directly involved in the study, including assistant physicians, pharmacists, nurses, and coordinators

Locations (1)

Amiens, Picardie, France