Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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: (i) Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential of hydrogen (pH) < 7.2 (iii) Pleural fluid glucose < 60mg/dL (iv) Pleural fluid Lactate Dehydrogenase (LDH) > 1,000 IU/L - 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 Criteria

  • 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Once daily intrapleural enzyme therapy 		Participants will receive intrapleural enzyme therapy (IET) once daily for 3 consecutive days.
  • 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.
    Other names:
    • once daily lytics
    • tPA once daily
  • Drug: DNA degradation once daily
    Deoxyribonuclease (DNase) 5mg will be administered once a day as intrapleural enzyme therapy (IET) for 3 consecutive days.
    Other names:
    • DNase once daily
    • lytics once daily
Active Comparator
Twice daily intrapleural enzyme therapy 		Participants will receive intrapleural enzyme therapy (IET) twice daily 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.
    Other names:
    • lytics twice daily
    • tPA twice daily
  • Drug: DNA degradation twice daily
    Deoxyribonuclease (DNase) 5mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.
    Other names:
    • lytics twice daily
    • DNase twice daily

Recruiting Locations

Yale New Haven Hospital
New Haven, Connecticut 06510
Contact:
Erin DeBiasi, MD
203-785-4198
erin.debiasi@yale.edu

Northwestern University
Chicago, Illinois 60611
Contact:
Christopher Kapp, MD
312-695-3800
christopher.kapp@nm.org

Rush University Medical Center
Chicago, Illinois 60612
Contact:
James Katsis, MD
312-942-6744
James_Katsis@rush.edu

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Labib G Debiane, MD
866-434-0076
ldebian1@hfhs.org

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03766
Contact:
John Howe, MD
603-650-5533
John.E.Howe@hitchcock.org

UNC Chapel Hill
Chapel Hill, North Carolina 27514
Contact:
Hee Jae Choi, DO
919-966-2533
heejae.choi@unchealth.unc.edu

More Details

NCT ID
NCT07095361
Status
Recruiting
Sponsor
University of North Carolina, Chapel Hill