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NCT Number: NCT07666464

Comparison of 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.

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Key information

Conditions

Therapy Pleural Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Antoine DUMAZET, MD

PRINCIPAL_INVESTIGATOR

Asaël BERGER, MD

PRINCIPAL_INVESTIGATOR

Camille PIRIOU-GAROUTE, MD

PRINCIPAL_INVESTIGATOR

Charles- Hugo MARQUETTE, MD

PRINCIPAL_INVESTIGATOR

Cherifa GOUNANE, MD

PRINCIPAL_INVESTIGATOR

Christophe GUT-GOBERT, MD

PRINCIPAL_INVESTIGATOR

Damien BASILLE, Dr

CONTACT

[email protected]

Elise ARTAUD-MACARI, MD

PRINCIPAL_INVESTIGATOR

Elise NOELSAVINA, MD

PRINCIPAL_INVESTIGATOR

Frédéric GAGNADOUX, MD

PRINCIPAL_INVESTIGATOR

Gilles MANGIAPAN, MD

PRINCIPAL_INVESTIGATOR

Hugues MOREL, MD

PRINCIPAL_INVESTIGATOR

Ibrantina LUCENA, MD

PRINCIPAL_INVESTIGATOR

Jean MORIN, MD

PRINCIPAL_INVESTIGATOR

Jean STAENTZEL, MD

PRINCIPAL_INVESTIGATOR

Laure GOUBERT, MD

PRINCIPAL_INVESTIGATOR

Laure SEYER, MD

PRINCIPAL_INVESTIGATOR

Lidia PETIT, MD

PRINCIPAL_INVESTIGATOR

Marine GOSSET-WOIMANT, MD

PRINCIPAL_INVESTIGATOR

Marion DESQUIENS, MD

PRINCIPAL_INVESTIGATOR

Maxime FURSTENBERGER, MD

PRINCIPAL_INVESTIGATOR

Nina DE MONTMOLLIN, MD

PRINCIPAL_INVESTIGATOR

Thomas FLAMENT, MD

PRINCIPAL_INVESTIGATOR

Vincent DUCROCQ, MD

PRINCIPAL_INVESTIGATOR

Vincent IOOS, MD

PRINCIPAL_INVESTIGATOR

Xavier DEMANT, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intrapleural irrigation

Drug

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.

Standard care

Procedure

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.

Primary outcomes

  1. Number of treatment failure

    Time frame: at 30 days

    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.

Secondary outcomes

  1. Volume of pleural fluid drained from randomization

    Time frame: at day 3

    Volume of pleural fluid drained from randomization to day 3

  2. Incidence of adverse events

    Time frame: at 90 days

    Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction

  3. Intra-hospital mortality

    Time frame: at 30 days

  4. Intra-hospital mortality

    Time frame: at 90 days

  5. Rate of thoracic surgery

    Time frame: at 30 days

    Rate of thoracic surgery

  6. Rate of additional intrapleural enzyme therapy

    Time frame: at 30 days

    Rate of additional intrapleural enzyme therapy

  7. Length of hospital stay

    Time frame: at 90 days

    Length of hospital stay

  8. Change in the area of pleural opacity

    Time frame: at day 3

    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;

  9. Presence of a restrictive ventilatory defect

    Time frame: at day 90

    Presence of a restrictive ventilatory defect, defined as total lung capacity < 80% of predicted values

  10. Assessment of pain using a numeric pain scale

    Time frame: at 90 days

    Assessment of pain using a numeric pain scale

  11. valuation of the prognostic performance of the RAPID score

    Time frame: at day 0

    valuation of the prognostic performance of the RAPID score

Study contacts

Contact information is provided by the study sponsor or research team.

Damien BASILLE, Pr

CONTACT

[email protected]

33+3 22 45 59 10

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

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

Registry information

Official study title

Randomized Controlled Trial Comparing an Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.

Acronym: EPISSOC

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 24, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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