Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT03873766
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Clinical presentation compatible with pleural infection (fever or leukocytosis, elevated procalcitonin, elevated C-reactive protein (CRP))
* Pleural fluid requiring drainage that is either:
* Macroscopically purulent or
* Positive on culture for bacterial infection or
* Positive for bacteria on gram stain or
* Lactate dehydrogenase (LDH) \> 1000 IU/L or
* Glucose \<40 mg/dL
Exclusion Criteria:
* Age \<18 years
* Unable to give consent (No surrogate consent of legally authorized representatives allowed for this study)
* Not proficient in English
* History of prior ipsilateral empyema
* Has known sensitivity to DNase or alteplase
* History of intracranial hemorrhage or acute intracranial hemorrhage
* History of stroke, hemorrhage, or trauma within the last 3 months
* Has had prior surgery on the side of the pleural infection
* Patients who are pregnant or lactating
* Expected survival less than 6 months from a different pathology to this pleural infection based on clinical judgment
* Has a tunneled pleural catheter in place
* Patients on anticoagulation that cannot be interrupted for surgical intervention
* Patients with known or suspected malignant pleural effusion
* Patients with renal failure (Creatinine clearance \<30)
* Prior history of or concern for chylothorax or pseudochylothorax
* Vulnerable populations: prisoners
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03873766
Study Brief:
Protocol Section:
NCT03873766