[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07095361":3,"trial-entities:NCT07095361":234,"trial-summary:NCT07095361":239},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":70,"secondary_outcomes":75,"sex":109,"minimum_age":110,"maximum_age":17,"healthy_volunteers":111,"eligibility_criteria":112,"std_ages":131,"locations":134,"central_contacts":226,"overall_officials":227,"references":232,"see_also_links":233},"NCT07095361","24-1309","Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema","Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)","RECRUITING","2028-09-30","2026-04","2026-05-19","2025-09-11","University of North Carolina, Chapel Hill","OTHER",true,"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.\n\nThe investigators are trying to learn:\n\n* Does using the medicine once a day work just as well as using it twice a day?\n* Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?\n* Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?\n\nParticipants will:\n\n* 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.\n* Be asked to give permission to join the study.\n* Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.",null,[19,20,21,22,23,24,25,26],"Pleural Infection Bacterial","Pleural Infections","Pleural Infections and Inflammations","Empyema, Pleural","Empyema","Complicated Pleural Effusion\u002F Empyema","Pleural Effusion Associated With Pulmonary Infection","Pleural Effusion",[28,29,30,31],"Lytics","Intrapleural enzyme therapy","Once daily","lytic therapy","INTERVENTIONAL","TREATMENT",[35],"PHASE4",{"count":37,"type":38},270,"ESTIMATED",[40,49,57,64],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"DRUG","Fibrinolytic once daily","tissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.",[45],"Once daily intrapleural enzyme therapy",[47,48],"once daily lytics","tPA once daily",{"type":41,"name":50,"description":51,"armGroupLabels":52,"otherNames":54},"Fibrinolytic twice daily","tissue plasminogen activator (tPA) 10mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.",[53],"Twice daily intrapleural enzyme therapy",[55,56],"lytics twice daily","tPA twice daily",{"type":41,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"DNA degradation once daily","Deoxyribonuclease (DNase) 5mg will be administered once a day as intrapleural enzyme therapy (IET) for 3 consecutive days.",[45],[62,63],"DNase once daily","lytics once daily",{"type":41,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"DNA degradation twice daily","Deoxyribonuclease (DNase) 5mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.",[53],[55,69],"DNase twice daily",[71],{"measure":72,"description":73,"timeFrame":74},"IET Failure: Surgery and\u002For mortality at 90 days","Measure the rate of IET failure (defined as surgery and\u002For mortality at 90 days) in both once daily IET and twice daily IET groups.","90 days",[76,80,83,87,90,93,96,99,102,106],{"measure":77,"description":78,"timeFrame":79},"30 Day Mortality","Evaluate rate of mortality at 30 days between the participants receiving once daily IET and twice daily IET","30 days",{"measure":81,"description":82,"timeFrame":74},"Hospital length of stay","Evaluate length of hospitalization stay between the participants receiving once daily IET and twice daily IET",{"measure":84,"description":85,"timeFrame":86},"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.","From enrollment until day 3 of intervention",{"measure":88,"description":89,"timeFrame":86},"Change of White Blood Cell Count","Evaluate the difference between white blood cell (WBC) count in units of cells per microliter (cells\u002FμL) between once daily IET and twice daily IET.",{"measure":91,"description":92,"timeFrame":86},"Change in C-reactive Protein (CRP) level","Evaluate the difference between C-reactive protein (CRP) level, in milligrams per liter (mg\u002FL) or milligrams per deciliter (mg\u002FdL), between once daily IET and twice daily IET.",{"measure":94,"description":95,"timeFrame":86},"Change in Fever","Evaluate the difference between fever (in Celsius) between once daily IET and twice daily IET",{"measure":97,"description":98,"timeFrame":86},"Chest tube drainage amount","Evaluate the difference in amount (mL) of pleural fluid drained between once daily and twice daily IET groups",{"measure":100,"description":101,"timeFrame":74},"Duration of chest tube placement","Evaluate the number of days of chest tube placement between once daily and twice daily IET groups",{"measure":103,"description":104,"timeFrame":105},"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","From enrollment to 48 hours after completing 3 days of intrapleural enzyme therapy",{"measure":107,"description":108,"timeFrame":105},"Percent of participants who have pleural hemorrhage requiring blood transfusion","Measure the percent of participants who have pleural hemorrhage requiring blood transfusion","ALL","18 Years",false,{"inclusion":113,"exclusion":120,"raw_text":130},[114,115,116,117,118,119],"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:","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",[121,122,123,124,125,126,127,128,129],"Known pregnancy or lactating females","Prisoners","Age \\\u003C18 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","Inclusion Criteria:\n\n* 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.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.\n* Age ≥ 18 years at the time of consent.\n* 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\n* Pleural fluid that is one of the following:\n\n  (i) Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential of hydrogen (pH) \\\u003C 7.2 (iii) Pleural fluid glucose \\\u003C 60mg\u002FdL (iv) Pleural fluid Lactate Dehydrogenase (LDH) \\> 1,000 IU\u002FL\n* 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\n\nExclusion Criteria:\n\n* Known pregnancy or lactating females\n* Prisoners\n* Age \\\u003C18 years at time of consent\n* Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission\n* Known sensitivity or allergic reaction to DNAse or tPA\n* Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days\n* Previous pneumonectomy or active bronchopleural fistula on the affected side\n* Therapeutic systemic anticoagulation or antiplatelet agents that cannot held for more than 48 hours prior to IET administration\n* Expected survival of less than 3 months due to a pathologic condition other than that causing the pleural infection",[132,133],"ADULT","OLDER_ADULT",[135,153,168,179,194,209],{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":140,"contacts":141,"geoPoint":150},"Yale New Haven Hospital","New Haven","Connecticut","06510","United States",[142,147],{"name":143,"role":144,"phone":145,"email":146},"Erin DeBiasi, MD","CONTACT","203-785-4198","erin.debiasi@yale.edu",{"name":148,"role":144,"email":149},"Study Coordinator","zubaida.dabre@yale.edu",{"lat":151,"lon":152},41.30815,-72.92816,{"facility":154,"status":8,"city":155,"state":156,"zip":157,"country":140,"contacts":158,"geoPoint":165},"Northwestern University","Chicago","Illinois","60611",[159,163],{"name":160,"role":144,"phone":161,"email":162},"Christopher Kapp, MD","312-695-3800","christopher.kapp@nm.org",{"name":148,"role":144,"email":164},"adriana.martinez@northwestern.edu",{"lat":166,"lon":167},41.85003,-87.65005,{"facility":169,"status":8,"city":155,"state":156,"zip":170,"country":140,"contacts":171,"geoPoint":178},"Rush University Medical Center","60612",[172,176],{"name":173,"role":144,"phone":174,"email":175},"James Katsis, MD","312-942-6744","James_Katsis@rush.edu",{"name":148,"role":144,"email":177},"Kimberly_P_Saulsberry@rush.edu",{"lat":166,"lon":167},{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":140,"contacts":184,"geoPoint":191},"Henry Ford Hospital","Detroit","Michigan","48202",[185,189],{"name":186,"role":144,"phone":187,"email":188},"Labib G Debiane, MD","866-434-0076","ldebian1@hfhs.org",{"name":148,"role":144,"email":190},"rgeorg11@HFHS.ORG",{"lat":192,"lon":193},42.33143,-83.04575,{"facility":195,"status":8,"city":196,"state":197,"zip":198,"country":140,"contacts":199,"geoPoint":206},"Dartmouth Hitchcock Medical Center","Lebanon","New Hampshire","03766",[200,204],{"name":201,"role":144,"phone":202,"email":203},"John Howe, MD","603-650-5533","John.E.Howe@hitchcock.org",{"name":148,"role":144,"email":205},"Bailey.D.Starr@hitchcock.org",{"lat":207,"lon":208},43.64229,-72.25176,{"facility":210,"status":8,"city":211,"state":212,"zip":213,"country":140,"contacts":214,"geoPoint":223},"UNC Chapel Hill","Chapel Hill","North Carolina","27514",[215,219],{"name":216,"role":144,"phone":217,"email":218},"Hee Jae Choi, DO","919-966-2533","heejae.choi@unchealth.unc.edu",{"name":220,"role":144,"phone":221,"email":222},"Ashley Delgado, BS","919-445-0367","ashley_delgado@med.unc.edu",{"lat":224,"lon":225},35.9132,-79.05584,[],[228],{"name":229,"affiliation":230,"role":231},"Jason Akulian, MD, MPH","University of North Carollina at Chapel Hill","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":235,"biomarkers":238},[236,23,237],"Complicated Pleural Effusion","Pleural Infection",[],{"nct_id":4,"found":15,"summary":240,"prompt_version":250},{"design":241,"status":242,"heading":243,"summary":244,"follow_up":245,"word_count":246,"commitments":247,"compensation":248,"drugs_mentioned":249},"This is an interventional study comparing once-daily versus twice-daily dosing of two medications. It plans to enroll 270 participants.","completed","Once Daily Intrapleural Enzyme Therapy for Pleural Infections","This study is looking at how often to give medications called tissue plasminogen activator (tPA) and deoxyribonuclease (DNase) to treat infections around the lungs (complicated parapneumonic effusion or empyema). These medications are put into the space between your lung and chest wall through a chest tube. Researchers want to see if giving these medications once a day works as well as giving them twice a day for 3 days. The main goal is to see if there's a difference in the need for surgery or risk of death within 90 days. You may be able to join if you are 18 years or older and have one of these pleural infections. The study plans to enroll 270 people, but its current status is unclear.","Your health outcomes, including surgery and mortality, will be monitored for 90 days after treatment.",124,"You would receive either tissue plasminogen activator (tPA) or deoxyribonuclease (DNase) once or twice daily for 3 consecutive days through a chest tube.","Not stated in the trial record.",[],"v2"]