[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474115":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":36,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":18,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous DNase I","EXPERIMENTAL","We will enroll up to 36 Participants; each is receiving repeated unit doses of DNase I, BID, delivered by IV infusion over 3 or 7 consecutive days (12 +\u002F- 1 hour apart) according to the following dose-escalation schedule with up to 6 Participants per dose panel.\n\n* Panel 1: 25 µg\u002Fkg, BID for 3 days (cumulative dose: 150 µg\u002Fkg)\n* Panel 2: 25 µg\u002Fkg, BID for 7 days (cumulative dose: 350 µg\u002Fkg)\n* Panel 3: 125 µg\u002Fkg, BID for 3 days (cumulative dose: 750 µg\u002Fkg)\n* Panel 4: 125 µg\u002Fkg, BID for 7 days (cumulative dose: 1750 µg\u002Fkg)",[13],"Drug: Intravenous DNase I",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","We will also enroll 12 septic Participants who do not receive intravenous DNase I (as Comparator Group). These patients will be recruited contemporaneously based on the same inclusion and exclusion criteria.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DRUG","Dose-escalating intravenous infusion of DNase I",[9],[25,31],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Alison Fox-Robichaud, MD","CONTACT","905 521 2100","4074","afoxrob@mcmaster.ca",{"name":32,"role":27,"phone":33,"phoneExt":34,"email":35},"Patricia Liaw, PhD","(905) 521-2100","40788","Patricia.Liaw@taari.ca",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hamilton Health Sciences","RECRUITING","Hamilton","Ontario","L8L 0A4","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.84963,43.25011,{"lat":49,"lon":48},[52],{"name":53,"role":27,"phone":18,"phoneExt":18,"email":18},"Alison E Fox-Robichaud, MD",{"type":55,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[57],{"name":58,"class":59},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100474115","phase-1-intravenous-dnase-i-for-the-treatment-of-sepsis-idealsepsisi-100474115",false,"NCT05453695","Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)","Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients","IDEALSepsisI","Inclusion Criteria:\n\n1. Age of ≥18 years\n2. Admitted to the ICU in the last 48 hours\n3. Suspected or proven infection as the admitting diagnosis\n4. A sequential (sepsis) organ function assessment (SOFA) score of ≥2 above baseline\n5. Expected to remain in the ICU for ≥ 72 hours\n\nExclusion Criteria:\n\n1. No consent\u002Finability to obtain consent from a substitute decision-maker\n2. Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock\n3. Have a significant risk of bleeding as evidenced by one of the following:\n\n   * Surgery requiring general or spinal anesthesia within 24 hours before enrolment\n   * The potential need for surgery in the next 24 hours\n   * Evidence of active bleeding\n   * A history of severe head trauma requiring hospitalization\n   * Intracranial surgery, or stroke within three months before the study\n   * Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system\n   * A history of congenital bleeding diatheses\n   * Gastrointestinal bleeding within five weeks before the study unless corrective surgery had been performed\n   * Trauma is considered to increase the risk of bleeding\n   * Presence of an epidural catheter\n   * Need for therapeutic anticoagulation\n4. Receiving DNase I by inhalation\n5. Terminal illness with a life expectancy of fewer than three months\n6. Pregnant and\u002For breastfeeding","ALL","18 Years","100 Years",{"count":72,"type":73},36,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.",[79,80],"Sepsis","Critical Illness","2026-03-02",{"date":83,"type":84},"2026-03-03","ACTUAL",{"date":86,"type":84},"2023-01-17",{"date":88,"type":73},"2026-09-30",{"name":5,"class":6},1]