[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pleural-effusion-associated-with-pulmonary-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pleural-effusion-associated-with-pulmonary-infection":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100600274","phase-4-once-daily-intrapleural-enzyme-therapy-in-complicated-parapneumonic-effusion-or-empyema-100600274",false,"NCT07095361","Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema","Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)","ONLY ONCE","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","ALL","18 Years",{"count":20,"type":21},270,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","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.",[27,28,29,30,31,32,33,34],"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",[36,37,38,39],"Lytics","Intrapleural enzyme therapy","Once daily","lytic therapy","RECRUITING","2026-05-14",{"date":43,"type":44},"2026-05-19","ACTUAL",{"date":46,"type":44},"2025-09-11",{"date":48,"type":21},"2028-09-30",{"name":50,"class":51},"University of North Carolina, Chapel Hill","OTHER",6,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100570910","phase-2-evaluating-the-efficacy-and-safety-of-saline-irrigation-as-an-add-on-therapy-for-retained-pleural-infections-lytics--100570910","NCT06713382","Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]","Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections (LYTICS +)","[LYTICS+]","Inclusion Criteria:\n\n* Age ≥18 years.\n* Presence of purulent pleural fluid or pleural fluid analysis with any of the following:\n* pH ≤ 7.2.\n* Glucose \\\u003C 40 mg\u002FdL.\n* LDH \\> 1000 IU\u002FL.\n* Presence of bacterial or fungal organisms on Gram stain or culture.\n* Chest tube placement with less than 200 mL drainage in 24 hours.\n* Indication for IPFT treatment based on treating physician's criteria.\n* Radiographic evidence of septations on chest ultrasound (US) or loculations on low-dose chest computed tomography (CT).\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Pregnant patients.\n* Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy).\n* Complicated sympathetic effusion.\n* Hepatic hydrothorax.",{"count":62,"type":21},96,[64],"PHASE2","The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct to standard interventions for treating retained pleural infections. Intrapleural fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with antibiotics and intercostal tube drainage, while saline irrigation serves as an alternative for cases with a high bleeding risk where IPFT is not feasible. The efficacy of saline irrigation combined with IPFT remains unexplored. The hypothesis is that saline irrigation could be an effective and safe addition to IPFT for patients with persistent pleural infections.\n\nThe specific aims of the study include:\n\nDetermine the efficacy of saline irrigation as add-on therapy to IPFT: Compare the clinical outcomes of patients receiving saline irrigation combined with IPFT to those receiving IPFT alone to determine if the addition of saline irrigation offers significant benefits. Outcomes include changes in inflammatory markers, imaging characteristics (echography and CT), volume of pleural fluid drained, chest tube duration, hospital length of stay, and the need for subsequent surgical intervention.\n\nAssess the safety and tolerability of saline irrigation plus IPFT: Compare complications and patient comfort in those receiving saline irrigation combined with IPFT to those receiving IPFT alone.",[33,67,68],"Pleural Effusion Disorder","Pleural Effusions",[34,70,71,72,73],"Thoracentesis","Tissue Plasminogen Activator","DNase","Therapeutic Irrigation","2025-05-21",{"date":76,"type":44},"2025-05-25",{"date":78,"type":44},"2025-04-10",{"date":80,"type":21},"2026-12-20",{"name":82,"class":51},"Beth Israel Deaconess Medical Center",1]