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Study Comparing Dornase Alfa and Alteplase with Surgery for Treating Pleural Empyema in Patients

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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 focused on studying the treatment of pleural empyema, a condition where pus gathers in the space between the lungs and the inner surface of the chest wall. The study will compare two different treatment approaches. One approach involves using medications called dornase alfa and alteplase, which are administered directly into the pleural space to help break down and clear the pus. The other approach is a surgical procedure known as VATS (Video-Assisted Thoracoscopic Surgery), which is a minimally invasive surgery used to remove the pus.

The purpose of the study is to determine whether the surgical procedure is more effective than the medication treatment in managing pleural empyema. Participants in the study will be randomly assigned to receive either the medication treatment or the surgical procedure. The study will last for a period of up to three weeks, during which the effects of the treatments will be monitored and compared.

Throughout the study, participants will receive regular medical assessments to ensure their safety and to evaluate the progress of their treatment. The findings from this study aim to provide valuable insights into the best treatment options for individuals suffering from pleural empyema.

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

    Joining the study

    Upon joining the study, the patient is randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving either treatment option.

  2. Step 2

    Treatment with medications

    The patient receives treatment for pleural empyema, a condition where pus accumulates in the space between the lungs and the chest wall.

    The treatment involves the use of two medications: dornase alfa and alteplase. Both medications are administered through a method called intrapleural use, which means they are delivered directly into the pleural space.

    The specific dosage and frequency of administration are determined by the study protocol, which is designed to ensure the safety and effectiveness of the treatment.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to the treatment are closely monitored. This includes regular check-ups and assessments to track progress and identify any potential side effects.

    The duration of the treatment and follow-up period is outlined in the study protocol, with the trial expected to conclude by October 2026.

  4. Step 4

    Comparison with surgical treatment

    The study aims to determine whether the medication treatment is as effective as a surgical procedure known as video-assisted thoracoscopic surgery (VATS). This comparison helps to evaluate the benefits and risks of each treatment option for patients with pleural empyema.

Who can join the trial?

4 criteria

  • The patient must have a condition called pleural empyema, which is an infection in the space around the lungs.
  • The patient must be between the ages of 18 and 64.
  • Both male and female patients can participate.
  • The patient should not be part of a vulnerable population, meaning they should not have additional factors that make them more at risk.

Who cannot join the trial?

3 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who have medical conditions other than pleural empyema. Pleural empyema is a condition where there is a collection of pus in the space between the lungs and the chest wall.
  • Patients who are part of a vulnerable population, which means groups of people who might need special protection or care.
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Investigated drugs

  • Intrapleural Fibrinolysis

    is a treatment used to break down fibrin, a protein involved in blood clotting, within the pleural space. This therapy helps to clear the infected fluid and pus from the pleural cavity, which is the space between the lungs and the chest wall, in patients with pleural empyema.

  • DNase

    is an enzyme therapy that helps to break down DNA in the pus, making it less viscous and easier to drain. This treatment is used in combination with intrapleural fibrinolysis to enhance the clearance of infected material from the pleural space in patients with pleural empyema.

  • VATS (Video-Assisted Thoracoscopic Surgery)

    is a minimally invasive surgical procedure used to treat pleural empyema. During VATS, a surgeon uses a small camera and instruments inserted through small incisions in the chest to remove infected tissue and fluid from the pleural space. This procedure is compared to intrapleural fibrinolysis and DNase therapy in the trial to determine which approach is more effective for treating pleural empyema.

What is already known about the treatment

  • DNase

    DNase is administered intrapleurally, meaning it is directly delivered into the pleural space. It is currently being studied in clinical trials for its effectiveness in treating pleural empyema, a condition where pus accumulates in the pleural cavity. The main therapeutic indication for DNase in this context is to help break down thick pus and debris, facilitating drainage. At the molecular level, DNase works by cleaving DNA strands, which reduces the viscosity of the pus. It is classified pharmacologically as an enzyme.

  • Fibrinolytic Agents

    Fibrinolytic agents are administered intrapleurally, directly into the pleural space. They are being evaluated in clinical trials for their role in treating pleural empyema. These agents are primarily used to break down fibrin, a protein involved in clot formation, to help clear the pleural space of pus and fibrinous material. The mechanism of action involves the conversion of plasminogen to plasmin, which then degrades fibrin clots. Fibrinolytic agents are classified as thrombolytics.

Investigated diseases

Pleural empyema – Pleural empyema is a condition where pus accumulates in the pleural cavity, the space between the lungs and the chest wall. It often develops as a complication of pneumonia, lung abscess, or chest surgery. The disease progresses through stages, starting with an initial exudative phase where fluid collects, followed by a fibrinopurulent phase where pus forms, and finally an organizing phase where the pleura may thicken and scar. Symptoms can include chest pain, fever, and difficulty breathing. As the condition advances, the pus can become more organized, making it harder to drain. If untreated, it can lead to restricted lung function due to the thickening of the pleural membranes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513596-40-00Estimated enrolment184 patientsSponsorOdense University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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