Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Phase 4Not Yet RecruitingNCT07095361

University of North Carolina, Chapel Hill270 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

270

Conditions

Pleural Infection Bacterial Pleural Infections

Interventions

Fibrinolytic once dailyDRUG

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

Fibrinolytic twice dailyDRUG

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

DNA degradation once dailyDRUG

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

DNA degradation twice dailyDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

IET Failure: Surgery and/or mortality at 90 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.

Time frame: 90 days

Secondary Outcomes

30 Day Mortality

Evaluate rate of mortality at 30 days between the participants receiving once daily IET and twice daily IET

Time frame: 30 days

Hospital length of stay

Evaluate length of hospitalization stay between the participants receiving once daily IET and twice daily IET

Time frame: 90 days

Oral Morphine Equivalents (OME)

Evaluate the difference in amount of oral morphine equivalents, which is a standardized method of reporting narcotic analgesic administration by converting opioid narcotics as determined by morphine milligram equivalents (MME) that would yield same result, for daily pain between once daily IET and twice daily IET.