[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538196":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":25,"armGroups":26,"interventions":21,"overallOfficials":21,"centralContacts":36,"locations":46,"responsibleParty":68,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":21,"enrollmentInfo":84,"targetDuration":87,"studyType":88,"phases":21,"briefSummary":89,"conditions":90,"keywords":21,"overallStatus":49,"whyStopped":21,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Mater Dei Hospital, Malta","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":21},[9,13],{"measure":10,"description":11,"timeFrame":12},"Molecular subtype assignments","Molecular subtype classification of sepsis patients using a consensus transcriptomic subtype model","Through study completion, an average of 2 year",{"measure":14,"description":15,"timeFrame":12},"Molecular information about the host response in patients with sepsis","Measurement of soluble mediators of host immune responses, including inflammation, coagulation, endothelial function",[17],{"measure":18,"description":19,"timeFrame":20},"Survival","Assessment of survival","3 years",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"CASE_CONTROL","PROSPECTIVE","All-cause sepsis, non-infectious critical illness, and control participants",[27,30,33],{"label":28,"type":21,"description":29,"interventionNames":21},"Sepsis (all-cause)","Suspected infection accompanied by organ dysfunction identified as a total SOFA score ≥ 2 points diagnosed within 24 hours after ITU admission. Definition in line with the Sepsis-3 criteria.",{"label":31,"type":21,"description":32,"interventionNames":21},"Non-infectious critical illness","Patients admitted to the ITU with non-infectious etiologies, including trauma.",{"label":34,"type":21,"description":35,"interventionNames":21},"Control subjects","Age-, sex-, and comorbidity-matched participants from the community or long term care facility",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":21,"email":41},"Brendon P. Scicluna, Ph.D.","CONTACT","+35623403869","brendon.scicluna@um.edu.mt",{"name":43,"role":39,"phone":44,"phoneExt":21,"email":45},"Stephen C. Sciberras, M.D.","+35625450000","stephen.sciberras@gov.mt",[47],{"facility":48,"status":49,"city":50,"state":21,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Mater Dei hospital, Intensive Therapy Unit","RECRUITING","Msida","MSD2080","Malta","MT",{"type":55,"coordinates":56},"Point",[57,58],14.48278,35.8925,{"lat":58,"lon":57},[61,63,66],{"name":62,"role":39,"phone":44,"phoneExt":21,"email":45},"Stephen Sciberras, MD",{"name":64,"role":39,"phone":44,"phoneExt":21,"email":65},"Godfrey Azzopardi, MD","godfrey.a.azzopardi@gov.mt",{"name":38,"role":67,"phone":21,"phoneExt":21,"email":21},"PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Brendon Scicluna, PhD","Assistant Professor and Principal Investigator",[72],{"name":73,"class":6},"University of Malta","100538196","molecular-subtype-specific-mechanisms-and-therapeutic-strategies-in-sepsis-100538196",false,"NCT06287684","Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis","MENDSEP","Inclusion criteria:\n\n* Age ≥ 18 years\n* Consent card signed\n\nExclusion criteria:\n\n* Consent card not signed\n* Pregnancy\n* Prisoners\n* Elective cardiac surgery patients with an uncomplicated stay.",true,"ALL","18 Years",{"count":85,"type":86},460,"ESTIMATED","12 Months","OBSERVATIONAL","Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular subtypes, or subclasses, with clinical implications. Classifying sepsis patients as molecular subtypes revealed that a poor prognosis subtype was characterized by immunosuppression and septic shock. Therefore, it has become essential to identify patients who may benefit from or be adversely affected by specific treatments, thereby identifying bona fide treatable traits or endotypes. The goal of this study is to assist the physician at the bedside in tailoring the treatment of an individual patient suffering from sepsis by generating rapid molecular information about immune status.",[91,92],"Sepsis","Septic Shock","2025-07-11",{"date":95,"type":96},"2025-07-16","ACTUAL",{"date":98,"type":96},"2023-09-13",{"date":100,"type":86},"2028-12-30",{"name":5,"class":6},1]