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EPISSOC : Randomized controlled trial comparing an Early Pleural Irrigation strategy with Saline to the Standard of Care for the management of complicated pleural infections

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524697-42-00
Enrollment
244
Registered
2026-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural infections

Brief summary

Treatment failure is defined as a composite outcome that includes death, the need for thoracic surgery, or the requirement for additional intrapleural enzyme therapy following randomisation. This endpoint will be assessed at 30 days.

Detailed description

Volume of pleural fluid drained from randomization to day 3, - Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction (assessed on day 3)., Intra-hospital mortality, as well as 30-day and 90-day mortality rates, Rate of thoracic surgery within 30 days, Rate of additional intrapleural enzyme therapy within 30 days., Length of hospital stay from randomization to discharge to home or transfer to a rehabilitation facility.

Interventions

DRUGClindamycin Abcur 150 mg/ml stungulyf/innrennslislyf
DRUGlausn.
DRUGPulmozyme 2500 U/2.5ml
DRUGδιάλυμα για εισπνοή μέσω εκνεφωτή
DRUGACTOSOLV 100 000 UI
DRUGLinezolid 2 mg/ml solution for infusion
DRUGActilyse 10 mg polvere e solvente per soluzione iniettabile e per infusione
DRUGCefepime AptaPharma 2 g powder for solution for injection/infusion
DRUGPiperacilline/Tazobactam Viatris 4 g/500 mg Pulver zur Herstellung einer Infusionslösung
DRUGAmoxicilline/Clavulaanzuur IBISQUS 2000 mg/200 mg poeder voor oplossing voor infusie
DRUGlösning
DRUGSODIUM CHLORIDE
DRUGCEFOTAXIME VIATRIS 2 g
DRUGpoudre pour solution injectable (IM - IV)
DRUGMetronidazole 500 mg/100 ml solution for infusion

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Treatment failure is defined as a composite outcome that includes death, the need for thoracic surgery, or the requirement for additional intrapleural enzyme therapy following randomisation. This endpoint will be assessed at 30 days.

Secondary

MeasureTime frame
Volume of pleural fluid drained from randomization to day 3, - Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction (assessed on day 3)., Intra-hospital mortality, as well as 30-day and 90-day mortality rates, Rate of thoracic surgery within 30 days, Rate of additional intrapleural enzyme therapy within 30 days., Length of hospital stay from randomization to discharge to home or transfer to a rehabilitation facility.

Outcome results

None listed

Source: EU CTIS · Data processed: May 19, 2026