Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Conditions

• Complicated Pleural Effusion/ Empyema
• Empyema
• Empyema, Pleural
• Pleural Effusion
• Pleural Effusion Associated With Pulmonary Infection
• Pleural Infection Bacterial
• Pleural Infections
• Pleural Infections and Inflammations

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fibrinolytic once daily — DRUG
  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 — DRUG
  tissue plasminogen activator (tPA) 10mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.
• DNA degradation once daily — DRUG
  Deoxyribonuclease (DNase) 5mg will be administered once a day as intrapleural enzyme therapy (IET) for 3 consecutive days.
• DNA degradation twice daily — DRUG
  Deoxyribonuclease (DNase) 5mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.

Study Details

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.

Key Dates

Start date

Sep 11, 2025

Status verified

Apr 2026

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

270 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Locations (6)

Find similar trials in New Haven, CT

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