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Intrapleural Alteplase and Dornase Alfa versus VATS for Patients with Pleural Empyema (Parapneumonic Pleural Infection)

Verified siteRegistered drugNo placebo
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What is this trial about?

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

A parapneumonic pleural infection, also called pleural empyema, is a buildup of infected fluid in the thin membrane that surrounds the lungs. When antibiotics and a chest tube to drain the fluid are not enough, two different ways to clear the infection are being compared. One approach uses a minimally invasive surgery known as VATS, which allows doctors to look inside the chest and clean the area through small cuts. The other approach uses medicines that are placed directly into the chest space; one of these is alteplase, an enzyme that helps dissolve clots, and the other is dornase alfa, a substance that breaks down thick mucus.

The purpose of the study is to determine which of these treatments leads to a shorter stay in the hospital for patients whose infection does not improve with the initial antibiotics and drainage. After a patient is enrolled, they receive either the surgical procedure or the medication combination, stay in the hospital while doctors watch for improvement, and are then followed for about a month to see how quickly they can leave the hospital and return to normal activities.

During the follow‑up, information is collected on how long the chest tube remains, any need for additional procedures, pain levels, ability to perform daily tasks, and overall quality of life. The study also looks at the costs related to health care and any loss of work time, helping to understand the broader impact of each treatment option.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After agreeing to join the study, basic information such as age, medical history, and current symptoms is recorded.

    Initial tests, including chest imaging and laboratory studies, are performed to confirm the diagnosis of parapneumonic pleural infection.

  2. Step 2

    Randomization to treatment group

    The patient is assigned by the study system to receive either actilyse or pulmozyme.

    The assignment is done without the patient needing to choose, ensuring unbiased comparison of the two treatments.

  3. Step 3

    Administration of study medication

    If assigned to actilyse, a single dose of 20 mg is prepared as a solution for injection and given directly into the pleural space (the area around the lungs) using a catheter.

    If assigned to pulmozyme, a single dose of 10 mg is prepared as a nebuliser solution and also delivered into the pleural space using the same catheter.

    Both medications are given by a trained health‑care professional and are intended to act on the infected pleural fluid.

  4. Step 4

    Post‑administration monitoring

    Vital signs such as heart rate, blood pressure, and breathing are checked regularly for any immediate reaction.

    The amount and character of fluid drained through the chest tube are recorded.

    Repeat chest imaging may be performed to see how the pleural space is responding to the medication.

  5. Step 5

    Chest tube management

    The chest tube remains in place to continue draining fluid until the treating team determines that drainage has stopped or is minimal.

    Criteria for removal include low daily output, improvement on imaging, and clinical stability.

  6. Step 6

    Daily clinical assessments

    Each day, health‑care staff evaluate pain level, need for pain medication, and any signs of infection.

    Antibiotic treatment continues according to standard practice for pleural infection, and any adjustments are documented.

  7. Step 7

    Discharge planning and hospital stay measurement

    When the patient meets predefined criteria for safety, the chest tube is removed and discharge is arranged.

    The total number of days spent in the hospital is recorded as the primary outcome of the trial.

  8. Step 8

    Post‑discharge follow‑up (up to 30 days)

    After leaving the hospital, the patient is contacted for follow‑up visits or telephone calls to assess recovery, pain, ability to perform daily activities, and any need for re‑intervention.

    These follow‑up interactions continue for a total of 30 days from the day of enrollment.

Who can join the trial?

4 criteria

  • Be 18 years old or older and have pneumonia (a lung infection) with a suspected parapneumonic pleural infection (infection of the lining around the lungs). This must be confirmed by fluid taken from the chest that is thick and yellow‑white (purulent), shows bacteria on a gram stain or grows bacteria in a laboratory culture, is acidic (has a pH lower than 7.2), has low sugar (glucose less than 2 mmol/L), and imaging (such as X‑ray or CT scan) that suggests the infection.
  • Be healthy enough for surgery, meaning you must be able to breathe with only one lung while the surgeon works (ventilated on one lung).
  • Have not improved after the first 24 hours of standard treatment, which includes a chest tube (a tube placed in the chest to drain fluid) and antibiotics (medicines that fight infection). Your doctor will decide this based on repeat imaging, lack of decrease in inflammation signs (called inflammatory markers), and how you feel.
  • Be able to understand the study and give informed consent (agree to take part after the doctors explain what will happen).

Who cannot join the trial?

9 criteria

  • Patients who are not healthy enough to have an operation (not fit for surgery).
  • Patients who would need an operation right away, such as when a doctor cannot obtain any fluid with a needle (direct surgery, also called a “dry tap”).
  • Patients who need more than two drainage tubes placed in the chest at the start (more than two chest tubes).
  • Patients who have any reason that makes a special chest‑inside enzyme treatment unsafe (contraindication to IET), such as a high risk of bleeding or an allergy.
  • Patients whose lung infection is caused by something other than pneumonia (parapneumonic pleural infection with another cause).
  • Patients who were treated for the same type of lung infection less than one year ago, or who have had lung surgery on the same side before.
  • Patients who are expected to live less than three months or who have a disease that cannot be cured (life expectancy <3 months or terminal illness).
  • Patients who are pregnant or are breastfeeding (pregnant or lactating).
  • Patients who have, or are suspected to have, an abnormal connection between the airway and the space around the lung (bronchopleural fistula).
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Investigated drugs

  • Alteplase

    is an enzyme that helps break down blood clots. In this trial it is given directly into the space around the lungs (intrapleural use) to help dissolve thick, fibrous material that can block the drainage of infected fluid. By clearing this material, the medication may allow the chest tube to work better and help patients recover faster, possibly shortening their stay in the hospital.

  • Dornase alfa

    is an enzyme that breaks down DNA, which is a major component of the thick pus that can build up in the chest during a severe lung infection. In the study, it is also administered directly into the pleural space to thin the infected fluid, making it easier to drain through the chest tube. This may improve the effectiveness of the drainage and help patients get better more quickly.

What is already known about the treatment

  • Alteplase

    This drug is supplied as a sterile solution for injection or infusion and is given directly into the pleural space (intrapleural use). It is an approved, widely studied medication that is commonly used to dissolve blood clots in various medical settings. In this trial it is used to break down fibrin deposits that can block fluid drainage in pleural infections. It works by activating plasminogen to plasmin, an enzyme that cuts fibrin, and it belongs to the class of thrombolytic (fibrinolytic) agents.

  • Dornase alfa

    This medication comes as a nebuliser solution that is also administered into the pleural space for this study. It is an approved drug, best known for treating cystic fibrosis, and has a solid record in medical literature. Here it helps to thin the thick, DNA‑rich fluid that builds up in empyema, making drainage easier. It is a recombinant form of the enzyme deoxyribonuclease that breaks down DNA, and it is classified as a mucolytic agent.

Investigated diseases

Parapneumonic empyema - It is an infection of the pleural space that occurs as a complication of pneumonia. The condition usually begins with a small amount of fluid that accumulates between the lung and chest wall. As bacteria grow, the fluid becomes purulent and the pleural lining becomes inflamed. The inflammation can cause the fluid to thicken and form fibrin strands that divide the space into separate pockets. Over time the pleural surfaces may develop a fibrous layer that restricts lung expansion. This progression can make breathing more difficult and may require medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526289-25-00Estimated enrolment164 patientsSponsorAmsterdam UMC Stichting

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