Parapneumonic Pleural Effusion Clinical Trials

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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Illinois
Northwestern University
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
Michigan
Henry Ford Hospital
RECRUITING
Detroit
North Carolina
UNC Chapel Hill
RECRUITING
Chapel Hill
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
Time Frame
Start Date: 2025-09-11
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 270
Treatments
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.
Sponsors
Collaborators: Yale University, Northwestern Memorial Hospital, Dartmouth-Hitchcock Medical Center, Henry Ford Health System, Rush University Medical Center
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov