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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • intrapleural irrigation
  • Standard care

Treatment groups

244 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Universitaire, Amiens

Lead sponsor

University Hospital, Toulouse

Collaborator

Central Hospital Saint Quentin

Collaborator

CRC CHI Creteil France

Collaborator

University Hospital, Tours

Collaborator

Centre Hospitalier Universitaire de Nīmes

Collaborator

University Hospital, Brest

Collaborator

CH Morlaix

Collaborator

University Hospital, Caen

Collaborator

University Hospital, Rouen

Collaborator

University Hospital, Angers

Collaborator

Hospices Civils de Lyon

Collaborator

CH Pontoise

Collaborator

CH Avignon

Collaborator

Centre Hospitalier VALENCIENNES

Collaborator

CH Le Havre

Collaborator

Tenon Hospital, Paris

Collaborator

University Hospital, Bordeaux

Collaborator

Centre Hospitalier Argenteuil

Collaborator

University Hospital, Strasbourg, France

Collaborator

Nantes University Hospital

Collaborator

CH Haguenau

Collaborator

CHU de Reims

Collaborator

Centre Hospitalier Alpes Leman

Collaborator

Central Hospital, Nancy, France

Collaborator