[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602761":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":60,"centralContacts":64,"locations":71,"responsibleParty":125,"collaborators":128,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":86,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":86,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":89,"whyStopped":86,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"National Kidney and Transplant Institute, Philippines","OTHER",[8,16,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic Plasma Component Therapy with Conventional Treatment (PPTTRT)","EXPERIMENTAL","This serves as the case arm for prophylactic plasma transfusion (PPT).\n\nParticipants in the PPTTRT arm will receive transfusion if the peripheral blood mononuclear cell (PBMC) complement factor I (CFI) quantitative real-time polymerase chain reaction (qPCR) deltaCT is found to be at least 25 or more. These participants will also be receiving standard of care treatment.\n\nParticipants in the PPTTRT arm with PBMC CFI qPCR deltaCT less than 25 will only be receiving standard of care treatment.\n\nIf a participant is found to have a Murray score of greater than or equal to 2.75 over the course of the hospital stay, they will undergo extracorporeal membrane oxygenation (ECMO).",[13,14,15],"Biological: Prophylactic Plasma Transfusion","Device: Extracorporeal Membrane Oxygenation","Other: Conventional therapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Conventional Treatment (PPTCONV)","ACTIVE_COMPARATOR","This serves as the control arm for prophylactic plasma transfusion (PPT).\n\nParticipants in the PPTCONV arm will only be receiving standard of care treatment.\n\nIf a participant is found to have a Murray score of greater than or equal to 2.75 over the course of the hospital stay, they will undergo extracorporeal membrane oxygenation (ECMO).",[14,15],{"label":22,"type":10,"description":23,"interventionNames":24},"Hemoperfusion Treatment with Conventional Treatment (HPTRT)","This serves as the case arm for hemoperfusion (HP).\n\nParticipants in the HPTRT arm will receive hemoperfusion and standard of care.\n\nParticipants with a Murray score of greater than or equal to 2.75 will undergo extracorporeal membrane oxygenation (ECMO) as a rescue treatment.",[25,14,15],"Device: Hemoperfusion",{"label":27,"type":18,"description":28,"interventionNames":29},"Conventional Treatment (HPCONV)","This serves as the control arm for hemoperfusion (HP).\n\nParticipants in the HPCONV arm will only be receiving standard of care.\n\nParticipants with a Murray score of greater than or equal to 2.75 will undergo extracorporeal membrane oxygenation (ECMO) as a rescue treatment.",[14,15],[31,41,48,54],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","Prophylactic Plasma Transfusion","ABO\u002FRh-type compatible fresh frozen plasma (FPP) units will be thawed to 37° prior to administration. Plasma transfusion will be administered intravenously, 1 unit for 4 hours every 12 hours. There will be two consecutive days for the transfusion for a total of 4 units.",[9],[37,38,39,40],"Prophylactic Plasma Component Transfusion","Plasma Transfusion","Prophylactic Plasma Component Therapy","PPT",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DEVICE","Hemoperfusion","The hemoperfusion (HP) procedure will follow the standard procedure of National Kidney and Transplant Institute (NKTI) using Jafron HA330 hemoperfusion cartridge. First, an internal jugular catheter is attached to the patient. Alternatively, an arteriovenous fistula or arteriovenous graft may be placed on the patient. The patient will then be hooked to a hemodialysis machine. Blood pump speed will be set to 150-200mL\u002Fmin, and HP will last for 2 to 2.5 hours. Whole blood will flow through the sorbent HA330 cartridge and back to the patient. Anticoagulation is not necessary due to the short treatment time. Hemoperfusion will be repeated after 12-24 hours for at least three days.",[22],[47],"HP",{"type":42,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Extracorporeal Membrane Oxygenation","A veno-venous ECMO (VV ECMO) will be applied by aseptically inserting a venous cannula into the femoral veins. The patients will be hooked to an ECMO machine. Patients without significant bleeding or vascular intervention will be managed with an activated clotting time set at 140-180 sec by 800-1000 U\u002Fh of heparin. Otherwise, heparin will be titrated to maintain a partial thromboplastin time of 60-80 sec.\n\nECMO settings are as follows:\n\n* Mean blood pressure of \\>60 mm\n* SaO2 at \\>90% with a flow of 3.5-4.5 L\u002Fmin\n* Hematocrit at \\>35%\n* Platelets \\>50000-100000\u002FmL\n* Transfusions will be done when necessary\n\nCriteria for weaning:\n\n* ABG:\n\n  * pH 7.35-7.45\n  * PaO2 \\>80 mm Hg\n  * PCO2 \\\u003C45 mm Hg\n* Under the following conditions:\n\n  * Gas blender FiO2 of 0.21\n  * Sweep gas of 0 L\u002Fmin at an ECMO flow of 2 L\u002Fmin\n  * Ventilator mode (if applicable):\n\n    * FiO2 of 0.6\n    * Tidal volume of 6 mL\u002Fkg\n    * PEEP of 8 cmH2O\n    * RR of 12-16\u002Fmin for VV ECMO or 3 L\u002Fmin of O2 via nasal prong with awakening ECMO patients",[27,17,22,9],[53],"ECMO",{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Conventional therapy","Conventional therapy for leptospirosis includes antibiotics, fluids, inotropes, renal replacement therapy, ventilator support, and other treatment that the attending physician deems necessary.",[27,17,22,9],[59],"Standard of care",[61],{"name":62,"affiliation":5,"role":63},"Romina A Danguilan, MD","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":69,"email":70},"Romina Danguilan, MD","CONTACT","(63)(02)8981-0300","1004","radanguilan@gmail.com",[72,87,109],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila","ACTIVE_NOT_RECRUITING","Manila","National Capital Region","1000","Philippines","PH",{"type":81,"coordinates":82},"Point",[83,84],120.9822,14.6042,{"lat":84,"lon":83},null,{"facility":88,"status":89,"city":75,"state":76,"zip":90,"country":78,"countryCode":79,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"San Lazaro Hospital","RECRUITING","1003",{"type":81,"coordinates":92},[83,84],{"lat":84,"lon":83},[95,99,100,103,105,107],{"name":96,"role":67,"phone":97,"phoneExt":86,"email":98},"Rontgene M Solante, MD","(63)(02)5309-9608","rontgenesolante@gmail.com",{"name":96,"role":63,"phone":86,"phoneExt":86,"email":86},{"name":101,"role":102,"phone":86,"phoneExt":86,"email":86},"Ana Ria Sayo-Abungan, MD","SUB_INVESTIGATOR",{"name":104,"role":102,"phone":86,"phoneExt":86,"email":86},"Jeffrey A Verona, MD",{"name":106,"role":102,"phone":86,"phoneExt":86,"email":86},"Jamie D Trifalgar-Arches, MD",{"name":108,"role":102,"phone":86,"phoneExt":86,"email":86},"Nathaniel Lee, MD",{"facility":110,"status":89,"city":111,"state":76,"zip":112,"country":78,"countryCode":79,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"National Kidney and Transplant Institute","Quezon City","1100",{"type":81,"coordinates":114},[115,116],121.0509,14.6488,{"lat":116,"lon":115},[119,120,121,123],{"name":62,"role":67,"phone":68,"phoneExt":69,"email":70},{"name":62,"role":63,"phone":86,"phoneExt":86,"email":86},{"name":122,"role":102,"phone":86,"phoneExt":86,"email":86},"Mel-hatra I Arakama, MD",{"name":124,"role":102,"phone":86,"phoneExt":86,"email":86},"Joselito R Chavez, MD",{"type":63,"investigatorFullName":126,"investigatorTitle":127,"investigatorAffiliation":5,"oldNameTitle":86,"oldOrganization":86},"Romina A. Danguilan","Deputy Executive Director for Medical Services",[129,132,134],{"name":130,"class":131},"San Lazaro Hospital, Philippines","UNKNOWN",{"name":133,"class":131},"Institute of Human Genetics, National Institutes of Health - University of the Philippines Manila, Philippines",{"name":135,"class":131},"Department of Science and Technology, Philippines","100602761","phase-2-preventive-strategies-for-early-and-late-complications-of-leptospirosis-100602761",false,"NCT07127718","Preventive Strategies for Early and Late Complications of Leptospirosis","Decreasing Leptospirosis Emergence Through Prognosis and Treatment Optimization (DeLEPTO) Project 1: Preventive Strategies for Early and Late Complications of Leptospirosis","Inclusion Criteria:\n\n* Subjects with acute fever (38ºC for at least two days) and at least one of the following: myalgia, jaundice, headache, meningeal irritation, oliguria, conjunctival suffusion\n* Who have a microscopic agglutination test (MAT) that indicates a single serum sample MAT titer greater than or equal to 1:400\n* Or a positive result for the latex agglutination test or a repeat test after seven days\n* Or a positive result for Leptospira IgG\u002FIgM lateral flow immunochromatographic test (ICT) or a repeat test within 3-14 days after the baseline test\n* Or a positive result for Leptospira polymerase chain reaction (PCR)\n* Or a positive blood culture of leptospira WITHOUT the complication specified in a subgroup of interest\n* PPTTRT\u002FPPTCONV: Not requiring ventilator support\n* HPTRT\u002FHPCONV: Dialysis Requiring Acute Kidney Injury. Defined as KDIGO Acute Kidney Injury Stage 3 or requiring renal replacement therapy to correct intractable acidosis, electrolyte abnormality, or over uremic encephalopathy or pericarditis\n* HPTRT\u002FHPCONV: Vasopressor Requiring - The subject must have received intravenous fluid resuscitation of a minimum of 30ml\u002Fkg within 24 hours of eligibility and still with hypotension (blood pressure less than 90\u002F60, MAP less than 65) requiring vasopressor support\n* HPTRT\u002FHPCONV: SOFA SCORE less than 15\n* ECMO: A Murray score of greater than or equal to 2.75\n\nExclusion Criteria:\n\n* Previous diagnosis of chronic kidney disease or on maintenance dialysis\n* Previous diagnoses of diseases associated with hemoptysis, such as bronchiectasis\n* Blood dyscrasias, malignancy, severe heart disease, HIV, cavitary PTB, Cirrhosis by ultrasound, severe malnutrition (Weight of less than 35kg)\n* Post cardiac arrest or those with GCS less than 8 at present. Participant has had chest compressions or CPR\n* Pregnancy\n* PPTTRT\u002FPPTCONV: Requiring emergent dialyses\n* PPTTRT\u002FPPTCONV: Significant lung pathology as defined by P\u002FF ratio less than 300, or obvious respiratory distress\n* PPTTRT\u002FPPTCONV: Presence of severe neurological symptoms\n* PPTTRT\u002FPPTCONV: Hypotension (or need for vasopressor support)\n* PPTTRT\u002FPPTCONV: Ongoing hemodynamic instability","ALL","18 Years","60 Years",{"count":147,"type":148},678,"ESTIMATED","INTERVENTIONAL",[151],"PHASE2","The goal of this clinical trial is to learn if complement factor I (CFI) works to predict development of complications in participants with leptospirosis. It will also learn if plasma transfusion, hemoperfusion, and extracorporeal membrane oxygenation works to treat participants with leptospirosis. The main questions it aims to answer are:\n\n* Does a low level of CFI predict the development of lung damage in participants with leptospirosis?\n* Does plasma tranfusion lower the chances of participants getting lung damage from leptospirosis?\n* Does hemoperfusion work to remove harmful materials from the blood of participants with leptospirosis?\n* Does extracorporeal membrane oxygenation increase the chance of survival in participants with lung damage?\n\nResearchers will compare plasma tranfusion and hemoperfusion to conventional therapy (standard of care for leptospirosis, including antibiotics, fluids, and other treatment that the doctor deems necessary) to see if these novel therapies work to treat leptospirosis.\n\nParticipants will:\n\n* Give blood samples for the study of CFI\n* Receive conventional therapy and\u002For plasma transfusion for 4 times in 2 days, OR\n* Receive conventional therapy and\u002For hemoperfusion for at least 3 days, AND\u002FOR\n* Receive extracorporeal membrane oxygenation if their condition worsens",[154],"Leptospirosis",[156,157,158,159,160,161,162,163,164],"leptospirosis","plasma transfusion","hemoperfusion","extracorporeal membrane oxygenation","complement factor I","CFI","complications","renal complications","pulmonary complications","2026-04-07",{"date":167,"type":168},"2026-04-13","ACTUAL",{"date":170,"type":168},"2024-04-12",{"date":172,"type":148},"2027-03",{"name":5,"class":6},3]