Early Saline Pleural Irrigation for Patients with Complicated Pleural Infections

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What is this study about?

This clinical trial is studying complicated pleural infections, which are serious infections in the space around the lungs. The purpose of the study is to compare an early pleural irrigation strategy, which means washing out the infected chest space with saline (salt water), with standard care. The study also uses usual infection treatment with antibiotics such as clindamycin, linezolid, vancomycin, cefepime, piperacillin/tazobactam, amoxicillin/clavulanic acid, cefotaxime, and metronidazole; in some cases, other treatments such as alteplase, urokinase, or dornase alfa may also be used to help clear fluid from the chest.

In this study, people are assigned to one of two treatment approaches. One group receives early pleural irrigation with saline along with standard treatment, while the other group receives standard care alone. Treatment is given during the hospital stay, and the patient is followed for about 30 days after treatment starts to see how the infection progresses and whether extra treatment is needed. The study is designed to see which approach works better for this type of chest infection.

Who Can Join the Study?

  • Be an adult, meaning 18 years of age or older.
  • Have a complicated pleural infection, meaning an infection in the space around the lungs that is serious enough to need treatment through a drainage tube.
  • Have pus-like fluid in the pleural space, meaning the fluid looks thick and infected.
  • Have a positive Gram stain, meaning a lab test on the fluid shows bacteria when it is looked at under a microscope.
  • Have a positive bacterial culture, meaning bacteria grow from the fluid in the laboratory test.
  • Have a loculated effusion, meaning the fluid is trapped in separate pockets instead of flowing freely.
  • Have a pleural fluid pH below 7.2, meaning the fluid is more acidic than normal, which can suggest a more serious infection.
  • Have a large amount of pleural fluid, meaning there is a great abundance of fluid around the lungs.
  • Need thoracic drainage, meaning a tube is placed in the chest to remove the infected fluid.
  • Have an initial ultrasound examination of the chest to measure how much fluid is present and to look for fibrinous septations, meaning thin internal strands or partitions in the fluid.
  • Have social security affiliation, meaning be enrolled in the required social security system.
  • Provide written informed consent, meaning sign a form showing they understand the study and agree to take part.

Who Cannot Join the Study?

  • Tuberculous pleural effusion, which means fluid around the lungs caused by tuberculosis.
  • Previous treatment with intrapleural fibrinolytic agents such as urokinase, streptokinase, alteplase, or DNase. These are medicines placed into the space around the lungs to help break down thick fluid or pus.
  • Previous treatment with intrapleural saline lavage, which means washing the space around the lungs with salt water.
  • Pregnancy or lactation (breastfeeding).
  • Expected survival of less than 3 months because of another serious medical condition not caused by the pleural problem.
  • Thoracic drainage for more than 24 hours, meaning a tube has already been draining fluid from the chest for longer than one day.
  • The patient is deprived of liberty by an administrative or court decision, or is under legal protection such as guardianship or supervision.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier D Avignon Avignon France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Universitaire Rouen Rouen France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Centre Hospitalier Alpes Leman 74130 France
Centre Hospitalier Pays de Morlaix Morlaix France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier De Haguenau Haguenau France
Centre Hospitalier De Valenciennes Valenciennes France
Cwgvlt Hyvibhaerxp Raqmradu Uknnjhapwnqjo Dz Tkxtf Tours France
Cbln Dz Nuvop Vandoeuvre Les Nancy France
Cnrrhf Hozavdorxka Ummpzvxeibmcu Rnhcf Reims France
Cvrasw Hgohnmkihqc Redypffu Dumffvtykoxxbz Angers France
Hdescgph Ugckeqsqhobmfc Syjkjuinzd &esnscg Hyhyrcs dp Hxqzvwxkocq STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
30.06.2026

Trial locations

Sodium chloride: This is sterile salt water used to rinse the space around the lungs early in the trial. It is given through the chest tube to help wash out infected fluid and pus, with the goal of improving drainage and helping the infection clear more quickly.

Clindamycin: This is an antibiotic given into a vein to treat bacteria that may be causing the pleural infection. It helps kill or stop the growth of certain germs while the infection is being treated.

Dornase alfa: This is an inhaled medicine that helps break down thick mucus. In this study background treatment, it is used to help make infected material thinner and easier to drain from the chest.

Urokinase: This is a medicine given into a vein that can help break down clots and thick material. In the context of this trial, it is part of the treatment used to help open up and drain the infected pleural space.

Linezolid: This is an antibiotic given into a vein to treat serious bacterial infections. It is used when doctors want strong coverage against certain bacteria that can cause pleural infection.

Alteplase: This is a clot-busting medicine given into a vein. In this trial setting, it is used to help break down thick infected material so it can drain more easily from around the lungs.

Cefepime: This is a broad-spectrum antibiotic given into a vein. It is used to treat a wide range of bacteria that may be involved in a complicated pleural infection.

Piperacillin/tazobactam: This is a combination antibiotic given into a vein. It helps treat many different types of bacteria, including some that are harder to kill, and is used as part of standard infection treatment.

Amoxicillin/clavulanic acid: This is a combination antibiotic given into a vein. It is used to fight bacteria that may be causing the infection, including some that can resist ordinary antibiotics.

Vancomycin: This is an antibiotic given into a vein. It is often used to treat serious infections caused by certain resistant bacteria, and it may be part of the standard care for pleural infection.

Cefotaxime: This is an antibiotic given into a vein. It helps treat bacterial infections and may be used as part of the standard treatment plan for the pleural infection.

Metronidazole: This is an antibiotic given into a vein that works well against certain bacteria, especially those that do not need oxygen to grow. It is used to help treat mixed infections in the chest.

Investigated diseases:

Pleural infection – A pleural infection is an infection of the thin space between the lung and the chest wall, where fluid can build up. It usually begins as a simple infected fluid collection and can progress to a more thickened, pus-like stage. As it advances, the fluid may become trapped in pockets and the lining around the lung may thicken. This can make the infection more difficult to clear and may lead to ongoing fluid buildup in the chest.

Trial ID:
2025-524697-42-00
Protocol code:
PI2025_843_0088
Trial Phase:
Therapeutic confirmatory (Phase III)

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    Investigated drugs:
    Denmark