Once-daily intrapleural enzyme treatment for complicated pleural infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Hospitalized adults with complicated parapneumonic effusion or empyema who already have a chest tube are randomized to receive intrapleural tissue plasminogen activator (tPA) plus DNase either once daily or twice daily while continuing standard care. The enzymes are instilled through the chest tube to break down loculated infected fluid and improve drainage. Outcomes include amount of residual pleural fluid on chest x-ray, need for additional procedures, and clinical recovery measures. Key enrollment criteria require purulent or culture-positive pleural fluid or biochemical markers of infection and persistent collection or sepsis after initial drainage.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arkansas Medical Center
  Little Rock, Arkansas, United States Recruiting
• Stanford Hospital
  Palo Alto, California, United States Recruiting
• UCSD Hillcrest Medical Center
  San Diego, California, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Jason Akulian, MD, MPH — University of North Carollina at Chapel Hill

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.