Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)

University of North Carolina (UNC)

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Drug: Fibrinolytic twice daily; Drug: DNA degradation twice daily; Drug: Fibrinolytic once daily; Drug: DNA degradation once daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07095361

24-1309

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Once daily intrapleural enzyme therapy

Experimental group

Description:

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

Treatment:

Drug: DNA degradation once daily

Drug: Fibrinolytic once daily

Twice daily intrapleural enzyme therapy

Active Comparator group

Description:

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

Treatment:

Drug: DNA degradation twice daily

Drug: Fibrinolytic twice daily