Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Summary

The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection.

The investigators are trying to learn:

* Does using the medicine once a day work just as well as using it twice a day?
* Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?
* Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?

Participants will:

* Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung.
* Be asked to give permission to join the study.
* Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.

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

Interventions

DRUG

Fibrinolytic once daily

tissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.

DRUG

Fibrinolytic twice daily

tissue plasminogen activator (tPA) 10mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.

DRUG

DNA degradation once daily

Deoxyribonuclease (DNase) 5mg will be administered once a day as intrapleural enzyme therapy (IET) for 3 consecutive days.

DRUG

DNA degradation twice daily

Deoxyribonuclease (DNase) 5mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.

Sponsors & Collaborators

• Northwestern Memorial Hospital

  collaborator OTHER

• Henry Ford Health System

  collaborator OTHER

• Yale University

  collaborator OTHER

• Rush University Medical Center

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-11

Primary Completion

2028-09-30

Completion

2028-09-30

FDA Drug

Yes

Countries

• United States

Study Locations