Chest infection showdown: drugs or surgery for empyema?
NCT ID NCT04095676
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether treating pleural empyema (a serious lung infection with pus in the chest cavity) with a drain and medication works as well as surgery. 184 adults with advanced-stage empyema will be randomly assigned to either video-assisted surgery or a less invasive approach using a small tube and drugs that break down pus. The main goal is to see which method leads to a shorter hospital stay.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- alteplase and dornase alfa (Pulmozyme) given into the chest cavity
- What this could lead to
- If it works, this could show that a less invasive drainage-and-medication approach is as good as or better than surgery for treating pleural empyema, potentially reducing recovery time and healthcare costs.
- What could go wrong
- This is a mid-stage trial with 184 participants, so results may not apply to all patients. Both treatments have risks, such as bleeding or infection, and the study may not find a clear winner.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 184 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2022
- Expected to finish
-
Oct 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years or more on the day of hospitalization * Must be able to provide informed consent * Acute hospitalization within the last 48 hours * Meeting diagnostic criteria for community acquired pleural infection using the following criteria: 1. A clinical presentation compatible with pleural infection AND 2. Has pleural fluid which is either: 1. purulent pleural fluid or 2. gram stain positive or 3. culture positive or 4. acidic with pH \< 7.2 or 5. low pleural fluid glucose (\< 2 mmol/L) in the absence of accurate pH measurement or 6. septated pleural fluid on ultrasound Exclusion Criteria: * • Pregnancy. Prior to inclusion of fertile women (defined as the period from menarche to postmenopause) a negative pregnancy test must be available * Breastfeeding * Declared terminally ill or a predicted survival of less than 3 months * Previous intrathoracic surgery (within \<1 year on the same side of the thorax as where the parapneumonic effusion/pleural empyema is located * Previously (within \<1 year) hospitalized with with complex parapneumonic effusion (stage II) or pleural empyema (stage III) * Drainage during the current admission on the same side of the thorax (excluding diagnostic pleural puncture) * Hospitalization within 7 days prior to current hospitalization * Previous allergic reaction to alteplase or DNase * Use of alteplase therapy contraindicated: * Ongoing treatment with oral anticoagulant incl. new oral anticoagulants (e.g. warfarin (Marevan), Dabigatranetexilat (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), Endoxaban (Lixiana)) * Significant ongoing bleeding or within last six months * Known haemorrhagic diathesis * Previous or suspected intracranial hemorrhage * Suspected subarachnoidal hemorrhage or condition following subarachnoidal hemorrhage from aneurysm * All forms of damage to the central nervous system (e.g. cerebral tumors, aneurysm, intracranial / spinal surgery) * Recent (within 10 days) cardiac resuscitation, birth, or perforation of non-compressible blood vessel (e.g. puncture of v. subclavia, v. jugularis) * Severe, uncontrolled arterial hypertension * Bacterial endocarditis, pericarditis * Acute pancreatitis * Documented ulcerative gastrointestinal disease within last 3 months, esophagal varices, arterial aneurysm, arterio-venous malformations * Tumor / malignancy with an increased risk of hemorrhage * Severe liver disease, including liver failure cirrhosis, portal hypertension (esophagal varices), and active hepatitis * Large operation or significant trauma within previous 3 months
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pleural empyema are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Aarhus University Hospital
RECRUITINGAarhus, Aarhus, 8200, Denmark
-
Odense University Hospital
RECRUITINGOdense, Denmark
-
Rigshospitalet
NOT_YET_RECRUITINGCopenhagen, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.