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Early Saline Pleural Irrigation for Patients with Complicated Pleural Infections

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>randomisation</b> and start of treatment

    After joining the study, you are assigned to one of two treatment groups by randomisation, which means the treatment group is chosen by chance.

    If you are assigned to the early pleural irrigation with saline group, you receive sodium chloride by respiratory use, with a total dose of 3 litres.

    If you are assigned to the standard care group, you receive treatment based on the medicines listed for background care. These may include clindamycin 900 mg by intravenous infusion, dornase alfa 2.5 mg by inhalation, urokinase 5000 units by intravenous infusion, linezolid 1200 mg by intravenous infusion, alteplase 90 mg by intravenous use, cefepime 6 g by intravenous injection or intravenous infusion, piperacillin/tazobactam 16 g by intravenous infusion, amoxicillin/clavulanic acid 6 g by intravenous use, vancomycin 2 g by intravenous use, cefotaxime 6 g by intravenous use, and metronidazole 1.5 g by intravenous infusion.

    The trial text does not specify the exact frequency or duration for these medicines, except for the study assessments listed below.

  2. Step 2

    <b>first 3 days</b> after randomisation

    During the first 3 days after randomisation, the amount of pleural fluid drained is measured. Pleural fluid is the fluid around the lungs.

    You are monitored for serious and non-serious adverse events, which are unwanted medical problems that happen during treatment.

    The events specifically listed for this period are fever, allergic reactions, bleeding, and chest tube obstruction. Chest tube obstruction means the tube used to drain fluid becomes blocked.

    These assessments are carried out on day 3.

  3. Step 3

    <b>up to 30 days</b> after randomisation

    By 30 days after randomisation, the study checks whether treatment failure has occurred. Treatment failure means death, the need for thoracic surgery (surgery in the chest), or the need for additional intrapleural enzyme therapy.

    The study also records the rate of thoracic surgery within 30 days.

    The study also records the rate of additional intrapleural enzyme therapy within 30 days.

    The length of your hospital stay is measured from randomisation until discharge to home or transfer to a rehabilitation facility.

  4. Step 4

    <b>up to 90 days</b> after randomisation

    The study records mortality at 90 days. Mortality means death.

Who can join the trial?

12 criteria

  • 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 trial?

7 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Clindamycin

    Clindamycin phosphate is given as a solution for intravenous infusion, so it is delivered directly into a vein by a healthcare professional. It is still widely used in medicine and is well described in medical literature, mainly for bacterial infections caused by certain germs, especially when infection may involve the lungs, skin, or soft tissues. It works by blocking bacterial protein production, which slows or stops the growth of the bacteria. It is a lincosamide antibiotic.

  • Dornase alfa

    Dornase alfa is inhaled as a nebuliser solution, meaning it is breathed in through a machine that turns the liquid into a fine mist. It is an established medicine in medical practice and literature, mainly used to help clear thick mucus in people with cystic fibrosis. It works by breaking down DNA in mucus, which makes the mucus thinner and easier to cough up. It is a mucus-thinning enzyme medicine, also called a recombinant deoxyribonuclease.

  • Urokinase

    Urokinase is given as a solution for intravenous infusion, so it is administered into a vein by medical staff. It has a long history in medicine and medical literature, mostly as a clot-busting treatment used when a blood clot needs to be dissolved. It works by turning plasminogen into plasmin, a natural substance that breaks down fibrin, which is the main material holding a clot together. It is a thrombolytic medicine.

  • Linezolid

    Linezolid is given as an intravenous infusion, which means it is infused into a vein over time. It is an established antibiotic in current medical practice and literature, often used for serious infections caused by resistant bacteria, including some lung, skin, and bloodstream infections. It works by blocking an early step in bacterial protein building, so the bacteria cannot grow well. It is an oxazolidinone antibiotic.

  • Alteplase

    Alteplase is supplied as a powder that is mixed into a solution and given by intravenous use, usually by trained medical staff. It remains an important medicine in medical practice and literature, especially for dissolving harmful blood clots in urgent situations. It works like a natural clot-dissolving enzyme by activating plasminogen into plasmin, which breaks down the clot framework. It is a thrombolytic medicine.

  • Cefepime

    Cefepime is given as a solution for injection or infusion into a vein, and it is administered by healthcare professionals. It is a well-established antibiotic in modern medicine and medical literature, used for many serious bacterial infections. It works by interfering with the bacterial wall, which is essential for the bacteria to survive and multiply. It is a fourth-generation cephalosporin antibiotic.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524697-42-00Protocol codePI2025_843_0088Estimated enrolment244 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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