A Phase 4 interventional study of Fibrinolytic once daily and Fibrinolytic twice daily in Pleural Infection Bacterial, Pleural Infections and Pleural Infections and Inflammations, sponsored by University of North Carolina, Chapel Hill. Recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of North Carolina, Chapel Hill · Phase 4, Interventional, and Treatment
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:
Participants will:
33 studies on the registry are indexed under Empyema, Pleural; 11 are open to participants now.
This study's planned enrollment of 270 is above the median of 77 across 26 interventional studies indexed under Empyema, Pleural.
Browse Empyema, Pleural studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Empyema, Pleural, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive intrapleural enzyme therapy (IET) once daily for 3 consecutive days.
Drug: Fibrinolytic once daily · Drug: DNA degradation once daily
Participants will receive intrapleural enzyme therapy (IET) twice daily for 3 consecutive days.
Drug: Fibrinolytic twice daily · Drug: DNA degradation twice daily
tissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.
Also known as: once daily lytics, tPA once daily
tissue plasminogen activator (tPA) 10mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.
Also known as: lytics twice daily, tPA twice daily
Deoxyribonuclease (DNase) 5mg will be administered once a day as intrapleural enzyme therapy (IET) for 3 consecutive days.
Also known as: DNase once daily, lytics once daily
Deoxyribonuclease (DNase) 5mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.
Also known as: lytics twice daily, DNase twice daily
IET Failure: Surgery and/or mortality at 90 days
Measure the rate of IET failure (defined as surgery and/or mortality at 90 days) in both once daily IET and twice daily IET groups.
Time frame: 90 days
30 Day Mortality
Evaluate rate of mortality at 30 days between the participants receiving once daily IET and twice daily IET
Time frame: 30 days
Hospital length of stay
Evaluate length of hospitalization stay between the participants receiving once daily IET and twice daily IET
Time frame: 90 days
Oral Morphine Equivalents (OME)
Evaluate the difference in amount of oral morphine equivalents, which is a standardized method of reporting narcotic analgesic administration by converting opioid narcotics as determined by morphine milligram equivalents (MME) that would yield same result, for daily pain between once daily IET and twice daily IET.
Time frame: From enrollment until day 3 of intervention
Change of White Blood Cell Count
Evaluate the difference between white blood cell (WBC) count in units of cells per microliter (cells/μL) between once daily IET and twice daily IET.
Time frame: From enrollment until day 3 of intervention
Change in C-reactive Protein (CRP) level
Evaluate the difference between C-reactive protein (CRP) level, in milligrams per liter (mg/L) or milligrams per deciliter (mg/dL), between once daily IET and twice daily IET.
Time frame: From enrollment until day 3 of intervention
Change in Fever
Evaluate the difference between fever (in Celsius) between once daily IET and twice daily IET
Time frame: From enrollment until day 3 of intervention
Chest tube drainage amount
Evaluate the difference in amount (mL) of pleural fluid drained between once daily and twice daily IET groups
Time frame: From enrollment until day 3 of intervention
Duration of chest tube placement
Evaluate the number of days of chest tube placement between once daily and twice daily IET groups
Time frame: 90 days
Difference in pleural opacification on chest x-ray imaging between once daily IET and twice daily IET
Measure the difference of pleural opacification on chest x-ray imaging, as measured in centimeter cubed (cm\^3), between once daily IET compared to twice daily IET
Time frame: From enrollment to 48 hours after completing 3 days of intrapleural enzyme therapy
Percent of participants who have pleural hemorrhage requiring blood transfusion
Measure the percent of participants who have pleural hemorrhage requiring blood transfusion
Time frame: From enrollment to 48 hours after completing 3 days of intrapleural enzyme therapy
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9/2026 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with University of North Carolina (UNC).
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of North Carolina, Chapel Hill →