Recruiting

tPA & DNase

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07095361

Conditions

Pleural Infection Bacterial

Pleural Infections

Pleural Infections and Inflammations

Empyema, Pleural

Empyema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fibrinolytic once daily

Fibrinolytic twice daily

DNA degradation once daily

DNA degradation twice daily

Study Details

Brief 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

Study ID

NCT07095361

Start date

Sep 11, 2025

Status verified date

Apr, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Once daily intrapleural enzyme therapy

Participants will receive intrapleural enzyme therapy (IET) once daily for 3 consecutive days.

active comparator: Twice daily intrapleural enzyme therapy

Participants will receive intrapleural enzyme therapy (IET) twice daily for 3 consecutive days.

Interventions

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.

Fibrinolytic twice daily

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

DNA degradation once daily

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

DNA degradation twice daily

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

Primary outcome measure

  • IET Failure: Surgery and/or mortality at 90 days [ Time Frame: 90 days ]

Central Contacts and Locations

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Erin DeBiasi, MD

203-785-4198erin.debiasi@yale.edu

Study Coordinator

zubaida.dabre@yale.edu

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Christopher Kapp, MD

312-695-3800christopher.kapp@nm.org

Study Coordinator

adriana.martinez@northwestern.edu

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

James Katsis, MD

312-942-6744James_Katsis@rush.edu

Study Coordinator

Kimberly_P_Saulsberry@rush.edu

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Labib G Debiane, MD

866-434-0076ldebian1@hfhs.org

Study Coordinator

rgeorg11@HFHS.ORG

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

John Howe, MD

603-650-5533John.E.Howe@hitchcock.org

Study Coordinator

Bailey.D.Starr@hitchcock.org

UNC Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Hee Jae Choi, DO

919-966-2533heejae.choi@unchealth.unc.edu

Ashley Delgado, BS

919-445-0367ashley_delgado@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

May 19, 2026

Last verified

Apr, 2026

Keywords

  • Lytics
  • Intrapleural enzyme therapy
  • Once daily
  • lytic therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-05-19.