Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

30. juni 2026 opdateret af: Centre Hospitalier Universitaire, Amiens

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

244

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
    • Picardie
      • Amiens, Picardie, Frankrig, 80054
        • Rekruttering
        • CHU Amiens Picardie
        • Ledende efterforsker:
          • Christophe GUT-GOBERT, MD
        • Ledende efterforsker:
          • Hugues MOREL, MD
        • Ledende efterforsker:
          • Frédéric GAGNADOUX, MD
        • Kontakt:
        • Ledende efterforsker:
          • Elise NOELSAVINA, MD
        • Ledende efterforsker:
          • Camille PIRIOU-GAROUTE, MD
        • Ledende efterforsker:
          • Gilles MANGIAPAN, MD
        • Ledende efterforsker:
          • Thomas FLAMENT, MD
        • Ledende efterforsker:
          • Vincent DUCROCQ, MD
        • Ledende efterforsker:
          • Laure SEYER, MD
        • Ledende efterforsker:
          • Elise ARTAUD-MACARI, MD
        • Ledende efterforsker:
          • Ibrantina LUCENA, MD
        • Ledende efterforsker:
          • Marine GOSSET-WOIMANT, MD
        • Ledende efterforsker:
          • Cherifa GOUNANE, MD
        • Ledende efterforsker:
          • Marion DESQUIENS, MD
        • Ledende efterforsker:
          • Charles- Hugo MARQUETTE, MD
        • Ledende efterforsker:
          • Laure GOUBERT, MD
        • Ledende efterforsker:
          • Nina DE MONTMOLLIN, MD
        • Ledende efterforsker:
          • Xavier DEMANT, MD
        • Ledende efterforsker:
          • Vincent IOOS, MD
        • Ledende efterforsker:
          • Maxime FURSTENBERGER, MD
        • Ledende efterforsker:
          • Jean MORIN, MD
        • Ledende efterforsker:
          • Asaël BERGER, MD
        • Ledende efterforsker:
          • Antoine DUMAZET, MD
        • Ledende efterforsker:
          • Lidia PETIT, MD
        • Ledende efterforsker:
          • Jean STAENTZEL, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of treatment failure
Tidsramme: 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.
at 30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Volume of pleural fluid drained from randomization
Tidsramme: at day 3
Volume of pleural fluid drained from randomization to day 3
at day 3
Incidence of adverse events
Tidsramme: at 90 days
Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction
at 90 days
Intra-hospital mortality
Tidsramme: at 30 days
at 30 days
Intra-hospital mortality
Tidsramme: at 90 days
at 90 days
Rate of thoracic surgery
Tidsramme: at 30 days
Rate of thoracic surgery
at 30 days
Rate of additional intrapleural enzyme therapy
Tidsramme: at 30 days
Rate of additional intrapleural enzyme therapy
at 30 days
Length of hospital stay
Tidsramme: at 90 days
Length of hospital stay
at 90 days
Change in the area of pleural opacity
Tidsramme: 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;
at day 3
Presence of a restrictive ventilatory defect
Tidsramme: at day 90
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
Tidsramme: at 90 days
Assessment of pain using a numeric pain scale
at 90 days
valuation of the prognostic performance of the RAPID score
Tidsramme: at day 0
valuation of the prognostic performance of the RAPID score
at day 0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire, Amiens

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI2025_843_0088

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Terapi

Kliniske forsøg med Standard care

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Congo, DR of

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner