TherapyPhase 3EPISSOCNCT07666464

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

A Phase 3 study testing intrapleural irrigation in people with Therapy and Pleural Infections, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Therapy, Pleural Infections
What is being tested?: intrapleural irrigation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 244 participants
Where: 1 siteFrance
Study dates: 13 May 2026to Aug 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Damien BASILLE, Pr contact

33+3 22 45 59 10

basille.damien@chu-amiens.fr

France1 site, 1 recruiting

CHU Amiens Picardie
Amiens, Picardie, 80054
Damien BASILLE, Dr, basille.damien@chu-amiens.fr
Elise NOELSAVINA, MD
Recruiting

Other trials in France

About this study

Official title: 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.

Conditions: Therapy, Pleural Infections
Being tested: intrapleural irrigation, Standard care
Keywords: therapy, pleural infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intrapleural irrigationDrug
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 careProcedure or surgery
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.

Study groups in NCT07666464
Study group	Role	What they receive
intrapleural irrigation	Experimental	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. Receives: Drug: intrapleural irrigation
standard care	Active comparator	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. Receives: Procedure: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of treatment failure
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.
Measured: at 30 days

Secondary outcomes (11)

Volume of pleural fluid drained from randomization
Volume of pleural fluid drained from randomization to day 3
Measured: at day 3
Incidence of adverse events
Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction
Measured: at 90 days
Intra-hospital mortality
Measured: at 30 days
Intra-hospital mortality
Measured: at 90 days
Rate of thoracic surgery
Rate of thoracic surgery
Measured: at 30 days
Rate of additional intrapleural enzyme therapy
Rate of additional intrapleural enzyme therapy
Measured: at 30 days
Length of hospital stay
Length of hospital stay
Measured: at 90 days
Change in the area of pleural opacity
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;
Measured: at day 3
Presence of a restrictive ventilatory defect
Presence of a restrictive ventilatory defect, defined as total lung capacity < 80% of predicted values
Measured: at day 90
Assessment of pain using a numeric pain scale
Assessment of pain using a numeric pain scale
Measured: at 90 days
valuation of the prognostic performance of the RAPID score
valuation of the prognostic performance of the RAPID score
Measured: at day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 2026Aug 2029

First posted24 Jun 2026
Study start13 May 2026
Primary completionMay 2029 (estimated)
Study completionAug 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for TherapyStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 244 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07666464
Sponsor's protocol ID: PI2025_843_0088
Acronym: EPISSOC
Status last verified: Jun 2026
First submitted: 18 Jun 2026
Last updated: 1 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Damien BASILLE, Pr

33+3 22 45 59 10

basille.damien@chu-amiens.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial Comparing an Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.
ClinicalTrials.gov ID: NCT07666464
Acronym / sponsor ID: EPISSOC / PI2025_843_0088
Conditions: Therapy, Pleural Infections
Keywords: therapy, pleural infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 244 participants (estimated)
Lead sponsor: Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
Collaborators: University Hospital, Toulouse, Central Hospital Saint Quentin, CRC CHI Creteil France, University Hospital, Tours, Centre Hospitalier Universitaire de Nīmes, University Hospital, Brest, CH Morlaix, University Hospital, Caen, University Hospital, Rouen, University Hospital, Angers, Hospices Civils de Lyon, CH Pontoise, CH Avignon, Centre Hospitalier VALENCIENNES, CH Le Havre, Tenon Hospital, Paris, University Hospital, Bordeaux, Centre Hospitalier Argenteuil, University Hospital, Strasbourg, France, Nantes University Hospital, CH Haguenau, CHU de Reims, Centre Hospitalier Alpes Leman, Central Hospital, Nancy, France
Study start: 13 May 2026 (actual)
Primary completion: May 2029 (estimated)
Study completion: Aug 2029 (estimated)
First posted: 24 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
intrapleural irrigation	Experimental	Drug: intrapleural irrigationExperimental 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.
standard care	Active comparator	Procedure: Standard careControl 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
intrapleural irrigation500 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.	Drug	intrapleural irrigation
Standard careStandard 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.	Procedure or surgery	standard care

Primary outcome

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.

11 secondary outcomes

Volume of pleural fluid drained from randomization
Time frame: at day 3
Incidence of adverse events
Time frame: at 90 days
Intra-hospital mortality
Time frame: at 30 days
Intra-hospital mortality
Time frame: at 90 days
Rate of thoracic surgery
Time frame: at 30 days
Rate of additional intrapleural enzyme therapy
Time frame: at 30 days
Length of hospital stay
Time frame: at 90 days
Change in the area of pleural opacity
Time frame: at day 3
Presence of a restrictive ventilatory defect
Time frame: at day 90
Assessment of pain using a numeric pain scale
Time frame: at 90 days
valuation of the prognostic performance of the RAPID score
Time frame: at day 0

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Individual participant dataSharing planned: No

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Not yet recruitingPhase 1
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Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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Active, not recruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Damien BASILLE, Pr contact

33+3 22 45 59 10

basille.damien@chu-amiens.fr

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing intrapleural irrigation in people with Therapy and Pleural Infections, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Damien BASILLE, Pr (33+3 22 45 59 10, basille.damien@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment failure (time frame: at 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07666464.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.