Ongoing Clinical Trials for Infectious Pleural Effusion
There is currently 1 ongoing clinical trial investigating treatment options for infectious pleural effusion, also known as pleural empyema. This trial is comparing medication-based treatment with surgical intervention to determine the most effective approach for managing this serious lung condition.
Clinical trial locations
- Denmark
Study Comparing Dornase Alfa and Alteplase with Surgery for Treating Pleural Empyema in Patients
This trial is investigating the best treatment approach for pleural empyema, a serious condition where pus collects in the space between the lungs and the chest wall. The study compares two different treatment methods to help doctors understand which approach works better for patients.
Main focus and goal: The trial aims to determine whether a minimally invasive surgical procedure called VATS (Video-Assisted Thoracoscopic Surgery) is more effective than medication treatment in managing pleural empyema. During the study period of up to three weeks, researchers will carefully monitor how well each treatment clears the infection and helps patients recover. VATS involves using a small camera and instruments inserted through tiny incisions in the chest to remove infected fluid and tissue. The medication approach uses two drugs delivered directly into the pleural space to break down and clear the pus without surgery.
Investigational drugs: The medication arm of the study uses two drugs administered directly into the pleural space. The first is dornase alfa, also known as DNase, an enzyme that breaks down DNA in the pus, making it thinner and easier to drain. The second is alteplase, a fibrinolytic agent that works by breaking down fibrin, a protein involved in blood clotting. Together, these medications help clear the infected material from the pleural cavity. These drugs are compared against VATS surgery to evaluate which treatment option provides better outcomes for patients.
Who can participate: The trial is open to adults between 18 and 64 years old who have been diagnosed with pleural empyema. Both men and women can participate. Patients must have this specific infection in the space around their lungs and should not have additional factors that make them particularly vulnerable or at higher risk.
Who cannot participate: The study excludes people outside the 18-64 age range. Patients with other medical conditions beyond pleural empyema are not eligible, as the trial focuses specifically on this infection. Additionally, individuals who are part of vulnerable populations requiring special protection or care cannot join the study.
How the trial works: When a patient joins the study, they are randomly assigned to receive either the medication treatment or the surgical procedure. This random assignment ensures that the comparison between treatments is fair. Those receiving medication will have dornase alfa and alteplase delivered directly into their pleural space according to a carefully designed protocol. Throughout the trial, patients receive regular medical assessments to monitor their safety and evaluate how well their treatment is working. The study is expected to conclude by October 2026.
Summary
Currently, there is one active clinical trial for infectious pleural effusion, taking place in Denmark. This study represents an important effort to determine the optimal treatment approach for pleural empyema by comparing established surgical methods with a combination medication therapy. The trial focuses specifically on adults in the working-age population (18-64 years) and uses a head-to-head comparison design to provide clear evidence about which treatment option delivers better results. The combination of dornase alfa and alteplase represents an interesting non-surgical alternative that could potentially spare some patients from needing invasive procedures, though the trial will determine whether it can match the effectiveness of surgery.
