Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
244
Countries
1
Sites
26
Pleural infections
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.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2026-05-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Funding from DGOS / PHRC-N- 2024 and CHU Amiens-Picardie
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
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.
Secondary objectives 9
- The volume of pleural fluid drained from randomization to day 3
- The incidence of serious and non-serious adverse events during the trial drug administration, including fever, allergic reactions, bleeding, and chest tube obstruction.
- The intra-hospital mortality as well as 30-day and 90-day mortality rates.
- The rate of thoracic surgery within 30 days.
- The rate of Intrapleural enzyme therapy within 30 days
- The length of hospital stay
- The improvements in radiographic clearance by day 3 (end of the trial drug administration).
- The lung function outcomes at 90 days.
- The residual pain at the time of discharge and again at 90 days.
Conditions and MedDRA coding
Pleural infections
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomized controlled trial comparing an Early Pleural Irrigation strategy with Saline to the Standa This study is a multicentre, open-label, randomized controlled trial comparing an early pleural irrigation strategy with saline to the standard of care for the management of complicated pleural infections requiring pleural drainage.
Eligible patients will be randomly assigned to one of two treatment groups. The experimental group will receive intrapleural irrigation with 500 mL of saline two times daily for a total of 6 irrigations (3 days). The control group will receive standard care, which includes maintaining tube patency with 20-mL normal saline flushes administered two times daily for 3 days.
Follow-up visits will occur after 3 days (for clinical evaluation), on day 7 (for clinical evaluation), on the day of discharge (for clinical evaluation), on day 30 (for primary outcome evaluation) and on day 90 after randomization (including clinical evaluation and lung function testing via spirometry and plethysmography).
|
Randomised Controlled | None | Experimental arm: Experimental group: Intrapleural irrigation with saline will be given twice daily for 3 days: Each irrigation will consist of the instillation of 500 mL of 0.9% sodium chloride solution via a giving set connected to the chest tube and a three-way tap, using a drip stand. The administration will be performed by gravity flow without the use of an infusion pump, and no external pressure will be applied to accelerate the infusion rate. Following the instillation, the chest tube will be left open to allow free drainage, combined with thoracic suction (−20 cmH₂O). This procedure will be repeated twice daily, for a total of six irrigations. Control arm: Control group: Standard care will consist of pleural drainage combined with regular chest tube maintenance. Chest tubes will be flushed twice daily for 3 consecutive days with 20 mL of 0.9% sodium chloride solution, administered via a sterile syringe to maintain tube patency. Thoracic suction (−20 cmH₂O) will be applied continuously to the chest tubes to facilitate pleural drainage. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Adults (≥18 years old)
- 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.
Exclusion criteria 6
- Tuberculous pleural effusions.
- Previous treatment with intrapleural fibrinolytic agents (urokinase, streptokinase, alteplase, or DNase) or intrapleural saline lavage.
- Pregnancy or lactation.
- Expected survival of less than 3 months, owing to a pathologic condition other than that responsible for the pleural abnormalities.
- Thoracic drainage since more than 24h
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 6
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- RESPIRATORY USE
- Max daily dose
- 3 l litre(s)
- Max total dose
- 3 l litre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 11
Actilyse 10 mg polvere e solvente per soluzione iniettabile e per infusione
PRD12386769 · Product
- Active substance
- Alteplase
- Substance synonyms
- RT-PA
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 90 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AD02 — ALTEPLASE
- Marketing authorisation
- 026533036
- MA holder
- BOEHRINGER INGELHEIM ITALIA S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Intrapleural fibrinolytic enzyme therapy (urokinase or tPA + DNase) may be used off-label as rescue therapy within routine clinical care and not as part of the investigational protocol, in accordance with international recommendations or data from the international literature (cf references : 9 – 13 – 29 – 30)
ACTOSOLV 100 000 UI, poudre pour solution injectable/pour perfusion
PRD7171020 · Product
- Active substance
- Urokinase
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSIÓN INTRAVENOSA
- Max daily dose
- 5000 U unit(s)
- Max total dose
- 250000 U unit(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AD04 — UROKINASE
- Marketing authorisation
- 34009 565 106 7 2
- MA holder
- EUMEDICA PHARMACEUTICALS GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Intrapleural fibrinolytic enzyme therapy (urokinase or tPA + DNase) may be used off-label as rescue therapy within routine clinical care and not as part of the investigational protocol, in accordance with international recommendations or data from the international literature (cf references : 9 – 13 – 29 – 30)
Pulmozyme 2500 U/2.5ml, διάλυμα για εισπνοή μέσω εκνεφωτή
PRD10001498 · Product
- Active substance
- Dornase Alfa
- Pharmaceutical form
- NEBULISER SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- R05CB13 — DORNASE ALFA (DESOXYRIBONUCLEASE)
- Marketing authorisation
- 90075/31-08-2022
- MA holder
- ROCHE (HELLAS) SA
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Intrapleural fibrinolytic enzyme therapy (urokinase or tPA + DNase) may be used off-label as rescue therapy within routine clinical care and not as part of the investigational protocol, in accordance with international recommendations or data from the international literature (cf references : 9 – 13 – 29 – 30)
Clindamycin Abcur 150 mg/ml stungulyf/innrennslislyf, lausn.
PRD11493522 · Product
- Active substance
- Clindamycin Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSIÓN INTRAVENOSA
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- IS/1/22/061/01
- MA holder
- ABCUR AB
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CEFOTAXIME VIATRIS 2 g, poudre pour solution injectable (IM - IV)
PRD11496280 · Product
- Active substance
- Cefotaxime
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 g gram(s)
- Max total dose
- 60 g gram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DD01 — -
- Marketing authorisation
- 34009 561 121 1 1
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Linezolid 2 mg/ml solution for infusion
PRD12086026 · Product
- Active substance
- Linezolid
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 16800 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- PL 56284/0033
- MA holder
- EUGIA (UK) LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cefepime AptaPharma 2 g powder for solution for injection/infusion
PRD10312931 · Product
- Active substance
- Cefepime Dihydrochloride Monohydrate
- Substance synonyms
- CEFEPIME HYDROCHLORIDE MONOHYDRATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 6 g gram(s)
- Max total dose
- 84 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DE01 — -
- Marketing authorisation
- MA1265/01002
- MA holder
- APTA MEDICA INTERNACIONAL D.O.O.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vancomycin Viatris 1 000 mg pulver till infusionsvätska, lösning
PRD10427270 · Product
- Active substance
- Vancomycin
- Substance synonyms
- VANCOMYCINUM
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 28 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 63256
- MA holder
- VIATRIS LIMITED
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Piperacilline/Tazobactam Viatris 4 g/500 mg Pulver zur Herstellung einer Infusionslösung
PRD10940259 · Product
- Active substance
- Piperacillin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INTRAVENOUS INFUSION
- Max daily dose
- 16 g gram(s)
- Max total dose
- 224 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- BE347873
- MA holder
- VIATRIS GX
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Metronidazole 500 mg/100 ml solution for infusion
PRD11697017 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSIÓN INTRAVENOSA
- Max daily dose
- 1.5 g gram(s)
- Max total dose
- 15 g gram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- P01AB01 — METRONIDAZOLE
- Marketing authorisation
- PL 56639/0011
- MA holder
- SVP PHARMA LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Amoxicilline/Clavulaanzuur IBISQUS 2000 mg/200 mg poeder voor oplossing voor infusie
PRD10103291 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 g gram(s)
- Max total dose
- 60 g gram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- RVG 129671
- MA holder
- IBI G. LORENZINI SPA
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- BASILLE Damien
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- BASILLE Damien
Locations
1 EU/EEA country · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 244 | 26 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier De Haguenau
intensive care, 64 Avenue Du Professeur Rene Leriche, 67500, Haguenau
Centre Hospitalier Universitaire Reims
Pneumology, Rue Du General Koenig, 51092, Reims Cedex
Centre Hospitalier Universitaire D'Angers
Respiratory and sleep Medicine, 4 Rue Larrey, 49100, Angers
Centre Hospitalier D Avignon
Pneumology, 305 Rue Raoul Follereau, 84000, Avignon
Centre Hospitalier Universitaire De Caen Normandie
Pneumology, Avenue De La Cote De Nacre, 14000, Caen
Centre Hospitalier De Valenciennes
Pneumology, 114 Avenue Desandrouin, 59300, Valenciennes
Hospices Civils De Lyon
Pneumology, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Nice
Pneumology, 30 Voie Romaine, 06000, Nice
Groupe Hospitalier Du Havre
Pneumology, 29 Avenue Pierre Mendes France, 76290, Montivilliers
Centre Hospitalier Universitaire De Toulouse
Pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
Les Hopitaux Universitaires De Strasbourg
Pneumology, 1 Place De L Hopital, 67000, Strasbourg
Centre Hospitalier Alpes-Leman
Pneumology, 558 Route De Findrol, 74130, Contamine-Sur-Arve
Centre Hospitalier De Saint-Quentin
Pneumology, 1 Rue Michel De L Hospital, 02100, Saint Quentin
Assistance Publique Hopitaux De Paris
Pneumology, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire Rouen
Pneumology and Thoracic Oncology, 1 Rue De Germont, 76000, Rouen
Centre Hospitalier Universitaire Amiens Picardie
Pneumology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Intercommunal Creteil
Pneumology, 40 Avenue De Verdun, 94000, Creteil
Centre Hospitalier Regional Universitaire De Tours
Pneumology, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Des Pays De Morlaix
Pneumology, 15 Rue De Kersaint Gilly, Bp 97237, Morlaix
Centre Hospitalier Victor Dupouy
Pneumology, 69 Rue Du Lieutenant Colonel Prudhon, 95107, Argenteuil Cedex
Centre Hospitalier Universitaire De Nantes
Pneumology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Hopital NOVO
Pneumology, 6 Avenue De L Ile De France, 95300, Pontoise
CHRU De Nancy
Pneumology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Nimes
Pneumology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Regional Et Universitaire De Brest
Internal Medicine and Pneumology, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Universitaire De Bordeaux
Pneumology, Avenue De Magellan, 33600, Pessac
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Annexe 5_CTCG Contraception guidline pages 11 and 10 | 1 |
| Protocol (for publication) | Annexe_4_Procedure pleural_irrigation_and_chest_tube_flushing_EPISSOC | 1 |
| Protocol (for publication) | Carte et Carnet patient EPISSOC | 1 |
| Protocol (for publication) | D1_ Protocol 2025-524697-42-00 | 1.1 |
| Protocol (for publication) | D1_ Protocol 2025-524697-42-00_avec suivi de modif | 1 |
| Protocol (for publication) | D1_ Protocol 2025-524697-42-00_avec suivi de modification | 1.3 |
| Protocol (for publication) | D1_ Protocol 2025-524697-42-00_Clean | 1 |
| Protocol (for publication) | D1_ Protocol 2025-524697-42-00_clean | 1 |
| Protocol (for publication) | D1_ Protocol avec suivi de modif 2025-524697-42-00 | 1.1 |
| Protocol (for publication) | PHRC_PHRC-21_Basille_Annexe_4_pleural_irrigation_and_chest_tube_flushing | 1 |
| Protocol (for publication) | Thal-Quick thoraxdrainage sets - instruction for use | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_ avec suivi de modif | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_ sans suivi de modif | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC CHLORURE DE SODIUM | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis avec suivi de modif_2025-524697-42-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-524697-42-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-524697-42-00_ avec suivi de modif | 1.3 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-524697-42-00_ clean | 1.3 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-524697-42-00_ version clean | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-26 | France | Acceptable 2026-05-18
|
2026-05-18 |