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

Randomized Controlled Trial Comparing an 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.

Study Overview

• Status: Recruiting
• Conditions: Therapy; Pleural Infections
• Intervention / Treatment: Procedure: Standard care; Drug: intrapleural irrigation

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Damien BASILLE, Pr; Phone Number: 33+3 22 45 59 10; Email: basille.damien@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Principal Investigator: Christophe GUT-GOBERT, MD
      • Principal Investigator: Hugues MOREL, MD
      • Principal Investigator: Frédéric GAGNADOUX, MD
      • Contact: Damien BASILLE, Dr; Email: basille.damien@chu-amiens.fr
      • Principal Investigator: Elise NOELSAVINA, MD
      • Principal Investigator: Camille PIRIOU-GAROUTE, MD
      • Principal Investigator: Gilles MANGIAPAN, MD
      • Principal Investigator: Thomas FLAMENT, MD
      • Principal Investigator: Vincent DUCROCQ, MD
      • Principal Investigator: Laure SEYER, MD
      • Principal Investigator: Elise ARTAUD-MACARI, MD
      • Principal Investigator: Ibrantina LUCENA, MD
      • Principal Investigator: Marine GOSSET-WOIMANT, MD
      • Principal Investigator: Cherifa GOUNANE, MD
      • Principal Investigator: Marion DESQUIENS, MD
      • Principal Investigator: Charles- Hugo MARQUETTE, MD
      • Principal Investigator: Laure GOUBERT, MD
      • Principal Investigator: Nina DE MONTMOLLIN, MD
      • Principal Investigator: Xavier DEMANT, MD
      • Principal Investigator: Vincent IOOS, MD
      • Principal Investigator: Maxime FURSTENBERGER, MD
      • Principal Investigator: Jean MORIN, MD
      • Principal Investigator: Asaël BERGER, MD
      • Principal Investigator: Antoine DUMAZET, MD
      • Principal Investigator: Lidia PETIT, MD
      • Principal Investigator: Jean STAENTZEL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intrapleural irrigation; Experimental group: 500 mL bags of 0.9% sodium chloride will be administered into the thoracic cavity via the chest tube using a three way tap and gravity (no infusion pump or pressure). The infusion is followed by free drainage with thoracic suction (up to -20 cmH2O). This process will occur twices daily for a total of 6 irrigations.	Drug: intrapleural irrigation; 500 mL bags of 0.9% sodium chloride will be administered into the thoracic cavity via the chest tube using a three way tap and gravity (no infusion pump or pressure). The infusion is followed by free drainage with thoracic suction (up to -20 cmH2O). This process will occur two times daily for a total of 6 irrigations.
Active Comparator: standard care; Control group: Standard care includes pleural drainage with 20 mL 0.9% sodium chloride flushes administered twice daily for 3 days to maintain tube patency. Thoracic suction (up to -20 cmH2O) will be applied to chest tubes.	Procedure: Standard care; Standard care includes pleural drainage with 20 mL 0.9% sodium chloride flushes administered two times daily for 3 days to maintain tube patency. Thoracic suction (up to -20 cmH2O) will be applied to chest tubes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment failure	Treatment failure, defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy. This criterion will be assessed at 30 days.	at 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of pleural fluid drained from randomization	Volume of pleural fluid drained from randomization to day 3	at day 3
Incidence of adverse events	Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction	at 90 days
Intra-hospital mortality		at 30 days
Intra-hospital mortality		at 90 days
Rate of thoracic surgery	Rate of thoracic surgery	at 30 days
Rate of additional intrapleural enzyme therapy	Rate of additional intrapleural enzyme therapy	at 30 days
Length of hospital stay	Length of hospital stay	at 90 days
Change in the area of pleural opacity	Change in the area of pleural opacity, measured as the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography from randomization to day 3;	at day 3
Presence of a restrictive ventilatory defect	Presence of a restrictive ventilatory defect, defined as total lung capacity < 80% of predicted values	at day 90
Assessment of pain using a numeric pain scale	Assessment of pain using a numeric pain scale	at 90 days
valuation of the prognostic performance of the RAPID score	valuation of the prognostic performance of the RAPID score	at day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Hospices Civils de Lyon; University Hospital, Strasbourg, France; University Hospital, Angers; University Hospital, Rouen; CHU de Reims; Central Hospital Saint Quentin; Central Hospital, Nancy, France; University Hospital, Bordeaux; University Hospital, Caen; Centre Hospitalier Universitaire de Nīmes; University Hospital, Brest; University Hospital, Toulouse; Nantes University Hospital; University Hospital, Tours; Tenon Hospital, Paris; Centre Hospitalier VALENCIENNES; CH Le Havre; Centre Hospitalier Argenteuil; CRC CHI Creteil France; Centre Hospitalier Alpes Leman; CH Pontoise; CH Morlaix; CH Avignon; CH Haguenau

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: therapy; pleural infections
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: PI2025_843_0088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No