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Once Daily Intrapleural Enzyme Therapy for Pleural Infections

This study is looking at how often to give medications called tissue plasminogen activator (tPA) and deoxyribonuclease (DNase) to treat infections around the lungs (complicated parapneumonic effusion or empyema). These medications are put into the space between your lung and chest wall through a chest tube. Researchers want to see if giving these medications once a day works as well as giving them twice a day for 3 days. The main goal is to see if there's a difference in the need for surgery or risk of death within 90 days. You may be able to join if you are 18 years or older and have one of these pleural infections. The study plans to enroll 270 people, but its current status is unclear.

Study design
This is an interventional study comparing once-daily versus twice-daily dosing of two medications. It plans to enroll 270 participants.
What's involved
You would receive either tissue plasminogen activator (tPA) or deoxyribonuclease (DNase) once or twice daily for 3 consecutive days through a chest tube.
Compensation
Not stated in the trial record.
Follow-up
Your health outcomes, including surgery and mortality, will be monitored for 90 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07095361

Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of North Carolina, Chapel Hill
~270 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Fibrinolytic once dailyFibrinolytic twice dailyDNA degradation once dailyDNA degradation twice daily

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
IET Failure: Surgery and/or mortality at 90 days
Measured over 90 days

Conditions

Pleural Infection Bacterial
Pleural Infections
Pleural Infections and Inflammations
Empyema, Pleural
Empyema
Complicated Pleural Effusion/ Empyema
Pleural Effusion Associated With Pulmonary Infection
Pleural Effusion

Explore related trials

Complicated Pleural EffusionEmpyemaPleural Infection

Where it's being run

6 sites across 5 states
Illinois2
Connecticut1
Michigan1
New Hampshire1
North Carolina1

Study leadership

  • Jason Akulian, MD, MPH · PRINCIPAL_INVESTIGATOR · University of North Carollina at Chapel Hill

Who to contact

Erin DeBiasi, MD
[email protected]
203-785-4198
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA authorization for release of personal health information.
Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
Age ≥ 18 years at the time of consent.
Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of IET
Pleural fluid that is one of the following:
Patient is deemed a candidate to receive intrapleural enzyme therapy as defined by having a residual collection or persistent sepsis 24 hours after initial chest tube placement

Exclusion

Known pregnancy or lactating females
Prisoners
Age \<18 years at time of consent
Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission
Known sensitivity or allergic reaction to DNAse or tPA
Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days
Previous pneumonectomy or active bronchopleural fistula on the affected side
Therapeutic systemic anticoagulation or antiplatelet agents that cannot held for more than 48 hours prior to IET administration
Expected survival of less than 3 months due to a pathologic condition other than that causing the pleural infection

What this trial measures

  • IET Failure: Surgery and/or mortality at 90 days90 days

    Measure the rate of IET failure (defined as surgery and/or mortality at 90 days) in both once daily IET and twice daily IET groups.