Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fibrinolytic once daily
  • Fibrinolytic twice daily
  • DNA degradation once daily
  • DNA degradation twice daily

Treatment groups

270 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

Northwestern Memorial Hospital

Collaborator

Henry Ford Health System

Collaborator

Yale University

Collaborator

Rush University Medical Center

Collaborator

Dartmouth-Hitchcock Medical Center

Collaborator