Comparison of Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections. (EPISSOC)
30. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
244
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Damien BASILLE, Pr
- Telefonnummer: 33+3 22 45 59 10
- E-post: basille.damien@chu-amiens.fr
Studiesteder
-
-
Picardie
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Amiens, Picardie, Frankrike, 80054
- Rekruttering
- CHU Amiens Picardie
-
Hovedetterforsker:
- Christophe GUT-GOBERT, MD
-
Hovedetterforsker:
- Hugues MOREL, MD
-
Hovedetterforsker:
- Frédéric GAGNADOUX, MD
-
Ta kontakt med:
- Damien BASILLE, Dr
- E-post: basille.damien@chu-amiens.fr
-
Hovedetterforsker:
- Elise NOELSAVINA, MD
-
Hovedetterforsker:
- Camille PIRIOU-GAROUTE, MD
-
Hovedetterforsker:
- Gilles MANGIAPAN, MD
-
Hovedetterforsker:
- Thomas FLAMENT, MD
-
Hovedetterforsker:
- Vincent DUCROCQ, MD
-
Hovedetterforsker:
- Laure SEYER, MD
-
Hovedetterforsker:
- Elise ARTAUD-MACARI, MD
-
Hovedetterforsker:
- Ibrantina LUCENA, MD
-
Hovedetterforsker:
- Marine GOSSET-WOIMANT, MD
-
Hovedetterforsker:
- Cherifa GOUNANE, MD
-
Hovedetterforsker:
- Marion DESQUIENS, MD
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Hovedetterforsker:
- Charles- Hugo MARQUETTE, MD
-
Hovedetterforsker:
- Laure GOUBERT, MD
-
Hovedetterforsker:
- Nina DE MONTMOLLIN, MD
-
Hovedetterforsker:
- Xavier DEMANT, MD
-
Hovedetterforsker:
- Vincent IOOS, MD
-
Hovedetterforsker:
- Maxime FURSTENBERGER, MD
-
Hovedetterforsker:
- Jean MORIN, MD
-
Hovedetterforsker:
- Asaël BERGER, MD
-
Hovedetterforsker:
- Antoine DUMAZET, MD
-
Hovedetterforsker:
- Lidia PETIT, MD
-
Hovedetterforsker:
- Jean STAENTZEL, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
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Incidence of adverse events
Tidsramme: at 90 days
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Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction
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at 90 days
|
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Intra-hospital mortality
Tidsramme: at 30 days
|
at 30 days
|
|
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Intra-hospital mortality
Tidsramme: at 90 days
|
at 90 days
|
|
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Rate of thoracic surgery
Tidsramme: at 30 days
|
Rate of thoracic surgery
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at 30 days
|
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Rate of additional intrapleural enzyme therapy
Tidsramme: at 30 days
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Rate of additional intrapleural enzyme therapy
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at 30 days
|
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Length of hospital stay
Tidsramme: at 90 days
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Length of hospital stay
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at 90 days
|
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Change in the area of pleural opacity
Tidsramme: at day 3
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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;
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at day 3
|
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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
|
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Assessment of pain using a numeric pain scale
Tidsramme: at 90 days
|
Assessment of pain using a numeric pain scale
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at 90 days
|
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. mai 2026
Primær fullføring (Antatt)
1. mai 2029
Studiet fullført (Antatt)
1. august 2029
Datoer for studieregistrering
Først innsendt
18. juni 2026
Først innsendt som oppfylte QC-kriteriene
18. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PI2025_843_0088
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Nei
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