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AuthorisedTherapeutic confirmatory (Phase III)Interventional

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

This research, called EPISSOC, is exploring the best way to manage severe chest infections affecting the lining of the lungs, known as pleural infections. Doctors are comparing an early wash-out, where they use salt water to clean the infected area, against the usual treatments. The main goal is to see if this early wash-out can help patients avoid serious outcomes like needing surgery or additional enzyme treatments, or even sadly, death, within 30 days of starting treatment. This is a Phase 3 study, which means it's a large trial testing if a new approach is truly better at treating the condition. We hope this research will lead to better care for people with these difficult infections.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Centre Hospitalier Universitaire Amiens Picardie
Enrolment target
244
Start
18 May 2026

What is this study about?

This research study, called EPISSOC, is designed to find the best way to treat a type of serious chest infection called a pleural infection. These infections happen in the space between your lungs and your chest wall, known as the pleura. When these infections become complicated, they can be very difficult to clear up.

Currently, there are different ways doctors approach these infections. This study is comparing whether an early wash-out strategy, using salt water to cleanse the infected area, works better than the standard treatments already in use. The main aim is to see if this early wash-out can reduce the chances of needing more intensive treatments, such as surgery, or other enzyme medicines, within 30 days of starting treatment. They also look at whether it can help prevent death.

By comparing these two approaches, the researchers hope to understand which method is most effective at helping patients recover faster and avoid serious complications. This is an important step in making sure that people with these challenging infections receive the best possible care.

Key takeaways

  • The study compares an early wash-out with salt water to standard treatments for pleural infections.
  • It aims to reduce the need for surgery or extra enzyme treatments.
  • You must be 18 or older to join, and both men and women can participate.
  • Your health will be closely monitored for up to 90 days after starting treatment.
  • Participants may receive one of several standard or experimental medications.
  • Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To be eligible for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part if they meet the other criteria.

Both men and women are welcome to participate in this research. The study needs to include a wide range of patients to get a clear picture of how effective the treatments are.

Before you can join, the study team will carefully review your medical history and current health to make sure that taking part is safe and appropriate for you. They will explain everything clearly and answer any questions you have.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a complicated pleural infection?
  3. Are you willing to potentially receive either the early wash-out or standard treatment?
  4. Are you able to attend follow-up assessments for up to 90 days?
  5. Do you have any other serious medical conditions that might exclude you? (A doctor will assess this.)
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the early wash-out treatment with salt water or the standard treatment for your pleural infection. All treatments involve medications that would be given through an infusion (into your vein) or inhaled. The study will track your progress closely. They will monitor how much fluid drains from your chest for the first three days, and also check for any side effects like fever, allergic reactions, bleeding, or issues with your chest drain. They will also look at how long you stay in hospital. You’ll be closely monitored for 30 days, and your overall health, including survival, will be checked at 30 and 90 days after you join the study. The total duration of your participation will include your hospital stay and then the follow-up checks at 30 and 90 days.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from a treatment that proves more effective than current standard care, potentially leading to a faster recovery or fewer complications. However, there are also potential risks related to the treatments, such as allergic reactions, bleeding, or issues with chest drains, which the study team will monitor closely. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is a pleural infection?

It's a serious infection that happens in the space between your lungs and your chest wall.

What does 'early wash-out' mean?

It's a procedure where doctors use salt water to clean the infected area in your chest early in your treatment.

What is 'standard care'?

This refers to the usual treatments that doctors currently give for pleural infections.

What is a Phase 3 study?

It's a large research study that tests if a new treatment approach is truly better at treating a condition.

Will I have to have surgery if I join?

The study aims to see if an early wash-out can help prevent the need for surgery, but surgery might still be necessary depending on how your infection progresses.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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