Fibrinolytic once daily
Drugtissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.
Other names: once daily lytics, tPA once daily
NCT Number: NCT07095361
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Yale New Haven Hospital, New Haven, Connecticut, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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
tissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.
Other names: 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.
Other names: lytics twice daily, tPA twice daily
Deoxyribonuclease (DNase) 5mg will be administered once a day as intrapleural enzyme therapy (IET) for 3 consecutive days.
Other names: DNase once daily, lytics once daily
Deoxyribonuclease (DNase) 5mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.
Other names: lytics twice daily, DNase twice daily
Time frame: 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: 30 days
Evaluate rate of mortality at 30 days between the participants receiving once daily IET and twice daily IET
Time frame: 90 days
Evaluate length of hospitalization stay between the participants receiving once daily IET and twice daily IET
Time frame: From enrollment until day 3 of intervention
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
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
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
Evaluate the difference between fever (in Celsius) between once daily IET and twice daily IET
Time frame: From enrollment until day 3 of intervention
Evaluate the difference in amount (mL) of pleural fluid drained between once daily and twice daily IET groups
Time frame: 90 days
Evaluate the number of days of chest tube placement between once daily and twice daily IET groups
Time frame: From enrollment to 48 hours after completing 3 days of intrapleural enzyme therapy
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
Measure the percent of participants who have pleural hemorrhage requiring blood transfusion
University of North Carolina, Chapel Hill
Other
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)
Acronym: ONLY ONCE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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