[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sepsis-and-septic-shock\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sepsis-and-septic-shock":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,71,102,126,153,182,214,243],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100583868","phase-4-eduction-in-immunosuppressive-regimen-among-kidney-transplant-recipients-patients-admitted-to-the-intensive-care-unit-for-septic-shock-andor-acute-respiratory-failure-100583868",false,"NCT06881927","Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and\u002For Acute Respiratory Failure","Reduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and\u002For Acute Respiratory Failure: a Multicenter, Open-label, Phase IIb Randomized Controlled Trial","REDIS","Inclusion Criteria:\n\n* \\- Adult patients, aged 18 years-old and over,\n* Kidney transplant recipients, with transplantation occurring more than 3 months prior to ICU admission\n* Patients admitted to the ICU in the setting of:\n\n  * Septic shock (sepsis requiring vasopressor support, with or without hyperlactatemia),\n  * And\u002For acute respiratory failure of presumed infectious origin (invasive or non-invasive ventilation, FiO2 greater than or equal to 50%),\n* Patients treated with at least an immunosuppressive bitherapy (including steroids, calcineurin inhibitors, mTOR inhibitors, azathioprine, or mycophenolate mofetil),\n* Patients affiliated with a social health insurance protection scheme,\n* Patients able of understanding the objectives and risks related to the research and providing a dated and signed informed consent. If patient is unable to consent: consent from relatives will be searched, and if absent, an emergency procedure will be process.\n* Women of childbearing potential, provided they have a negative blood pregnancy test on the day of the inclusion visit.\n\nExclusion Criteria:\n\n* Minor patients,\n* Patients unable to consent: under legal protection measures, patients deprived of liberty,\n* Kidney transplant recipients treated with Belatacept due to the persistent effect of Belatacept, it is not possible to modulate this treatment in a short term period,\n* Patients with severe chronic graft dysfunction (glomerular filtration rate \\\u003C 20 ml\u002Fmin\u002F1.73m² according to the CKD-EPI formula in the month prior to admission),\n* Transplant renal recipients who have already resumed RRT (hemodialysis or peritoneal dialysis),\n* Multi-organ transplant recipients,\n* Pregnant women","ALL","18 Years",{"count":20,"type":21},212,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Kidney transplantation is the treatment of choice for end-stage chronic kidney disease. Kidney transplantation is at the first rank of solid organ transplantation in France, with 3,376 grafts performed in 2022. Immunosuppressive therapy, required to prevent graft rejection, exposes graft recipients to complications related to decreased immunity, including opportunistic infections and neoplastic complications.\n\nAfter the earlt post-transplantation period, up to 10% of kidney transplant recipients will require admission to the intensive care unit (ICU). The main reasons for admission are septic shock and acute hypoxemic respiratory failure. ICU stay has a significant impact on these patients with a mortality rate reaching 40%, that remains increased even after ICU discharge. Furthermore, an impact on graft function has been demonstrated, with deterioration of graft function in 1\u002F3 of patients, and among those, up to one in two will require resumption of renal replacement therapy (RRT).\n\nAlthough the occurrence of septic shock or acute respiratory failure related to an infection is more common and severe, the optimal management strategy for immunosuppressors is not defined in kidney transplant recipients admitted to the ICU in those settings.\n\nMaintain a high level of immunosuppressive therapies may hinder the recovery from the acute critical condition. Furthermore, these treatments have a narrow therapeutic index; for instance, the management of calcineurin inhibitors is challenging in the ICU due to pharmacodynamic changes associated with the acute situation (distribution volume, organ failure) and the numerous potential drug interactions that carry inherent risks of overdose.\n\nthe investigators hypothesize that a reduction in the level of immunosuppressive treatments could promote recovery in kidney transplant recipients admitted to the ICU for septic shock and\u002For acute hypoxemic respiratory failure, without adversely affecting the risk of rejection or long-term renal prognosis.",[27,28,29,30],"Sepsis and Septic Shock","Acute Respiratory Failure","Kidney Transplant Recipients","Immunosuppressive Agents","RECRUITING","2026-06-03",{"date":34,"type":35},"2026-06-05","ACTUAL",{"date":37,"type":35},"2026-05-11",{"date":39,"type":21},"2029-06-01",{"name":41,"class":42},"University Hospital, Strasbourg, France","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100637995","mirna-quantification-in-patients-with-septic-shock-100637995","NCT07597122","MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK","MIRSEP - MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK","MIRSEP","Inclusion Criteria:\n\nSeptic shock:\n\n* New onset (\\\u003C24h) of septic shock diagnosis according to Sepsis-3 definition\n* (suspected) infection\n* Vasopressors required to maintain mean arterial pressure ≥65mm Hg (despite adequate fluid resuscitation)\n* Serum lactate level \\> 2mmol\u002FL\n* Minimum age of 18 years\n* Expected length of stay \\>48h\n* Written consent from an independent physician\n\nCritically ill:\n\n* Patients on mechanical ventilation (MV) in the ICU without an admission diagnosis of sepsis\u002Fseptic shock according to Sepsis-3 definition\n* Minimum age of 18 years\n* Expected length of stay \\>48h\n* Written consent from an independent physician\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Patients known not to speak German or French\n* Patients with known.\n\n  1. Pre-existing congenital or acquired severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS) or\n  2. current immunosuppressive therapy (immunosuppressive biologicals or active lymphocyte therapy e.g. endoxan, rituximab or corticosteroid use at a dose \\> 10 mg\u002Fday equivalent of prednisone. However, acute corticosteroid treatment of a relative adrenal insufficiency using a maximum hydrocortisone dose of 200 mg\u002Fday is accepted.",{"count":53,"type":21},56,"OBSERVATIONAL","Sepsis-induced immunosuppression (SIS) is a common complication in patients with septic shock. Reduced expression of Human leukocyte antigen isotype DR (HLA-DR) on circulating monocytes is a marker for SIS and correlates with risk of secondary infections and mortality. The miRSep study aims to improve the understanding of early microRNA (miRNA) mediated changes in HLA-DR on monocytes in patients with septic shock.",[27],[58,59,60,61,62],"Septic shock","Sepsis induced immunusuppression","HLA-DR","miRNA","Monocytes","2026-06-01",{"date":65,"type":35},"2026-06-02",{"date":63,"type":35},{"date":68,"type":21},"2027-12-31",{"name":70,"class":42},"Insel Gruppe AG, University Hospital Bern",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100627688","phase-2-adjunctive-fludrocortisone-in-septic-shock-100627688","NCT07451886","Adjunctive Fludrocortisone in Septic Shock","Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)","AFLUDROS-1","Inclusion Criteria:\n\n1. suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection\n2. ≥0.25 μg\u002Fkg\u002Fmin of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour\n3. onset of septic shock within 24 hours\n4. shock due to infection with no other proven or apparent cause\n5. hypoperfusion defined as arterial or venous lactate concentration \\>2.0 mmol\u002FL\n6. mechanical ventilation\n\nExclusion Criteria:\n\n1. fludrocortisone cannot be administered within 24 hours of onset of septic shock\n2. death is deemed imminent or inevitable by treating clinicians\n3. limitation of therapy\n4. an underlying disease process with a life expectancy of less than 90 days\n5. pregnancy (confirmed or suspected)\n6. receiving immunomodulatory agents including hydrocortisone \\> 300mg\u002Fday\n7. enteral medication cannot be administered\n8. prescribed fludrocortisone for other medical condition\n9. contraindication to hydrocortisone or fludrocortisone",{"count":80,"type":21},32,[82],"PHASE2","Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone.\n\nTo test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.",[85,86,87,27,88],"Sepsis","Septic Shock","Sepsis - to Reduce Mortality in the Intensive Care Unit","Sepsis at Intensive Care Unit",[90,58,85,91,92,93],"Fludrocortisone","hydrocortisone","intensive care unit","pilot",{"date":65,"type":35},{"date":96,"type":35},"2026-04-01",{"date":98,"type":21},"2028-07-31",{"name":100,"class":42},"Chinese University of Hong Kong",5,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":43},"100632634","dynamic-svo2-in-predicting-fluid-responsiveness-in-septic-shock-100632634","NCT07516236","Dynamic SvO2 in Predicting Fluid Responsiveness in Septic Shock","Diagnostic Accuracy of Dynamic Central Venous Oxygen Saturation in Predicting Fluid Responsiveness in Septic Shock: A Prospective Observational Study","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of septic shock according to Sepsis-3 criteria:\n\nSuspected or confirmed infection o Requirement for vasopressors to maintain MAP \\> 65 mmHg o Serum lactate \\> 2 mmol\u002FL despite adequate fluid resuscitation\n\nExclusion Criteria:\n\n* Pregnancy\n* Significant valvular heart disease.\n* Atrial fibrillation.\n* Inadequate echocardiographic window.\n* Ongoing bleeding or contraindication to fluid bolus.",{"count":110,"type":21},115,"This prospective observational diagnostic accuracy study investigates the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock, compared to measurements obtained using echocardiography (VTI) and cardiometry. We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.",[27],[114,115,116,86],"Diagnostic Accuracy","Dynamic Venous Oxygen Saturation","Fluid Responsiveness","NOT_YET_RECRUITING","2026-04-02",{"date":120,"type":35},"2026-04-07",{"date":96,"type":21},{"date":123,"type":21},"2027-02-01",{"name":125,"class":42},"Menoufia University",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100624858","written-sepsis-education-for-patients-100624858","NCT07415096","Written Sepsis Education for Patients","Setting Up For Success: A Pilot Feasibility Randomized Controlled Trial of Written Education for Sepsis Survivors","Inclusion Criteria:\n\n* Confirmed diagnosis of sepsis based on the sepsis-3 definition (infection + Sequential Organ Failure Assessment \\[SOFA\\] increase \\>2)\n* Admitted to an ICU\n* At least 18 years old at study commencement\n\nExclusion Criteria:\n\n* Unable to read basic English\n* Despite available accommodations, they lack the cognitive, mental, or physical capacity to complete study assessments by ICU discharge\n* Readmitted to ICU during their index hospital stay\n* Hospital length of stay surpasses 30 days.",{"count":134,"type":21},30,[136],"NA","This pilot feasibility randomized controlled trial (RCT) aims to determine if it feasible to recruit, deliver, and evaluate a written discharge educational material (a brochure) to adult Intensive Care Unit (ICU) patients diagnosed with sepsis.\n\nThe main questions it aims to answer are:\n\n1. Feasibility to identify and enroll \\>80% of eligible participants\n2. Feasibility to recruit 30 participants over a 6-month period\n3. Fidelity of intervention, assessed as \\>75% of participants receiving assigned intervention Researchers will assess the feasibility of comparing two groups: (1) Control - usual ICU discharge care, and (2) Intervention - usual ICU discharge care plus the receipt of an educational sepsis brochure and an explicit opportunity to ask questions about sepsis, answered by a trained intensive care unit (ICU) Registered Nurse.\n\nParticipants will receive intervention or control just prior to their discharge from ICU. They will complete online or phone survey assessments 24-48 hours post ICU discharge and 15-days post hospital discharge. Mortality and readmission data will additionally be assessed at 30-days post-discharge.",[85,27,88],[85,140,141,142,143],"Post-Sepsis Syndrome","Patient Education","Sepsis Rehabilitation","Care Transitions","2026-03-01",{"date":146,"type":35},"2026-03-03",{"date":148,"type":21},"2026-02",{"date":150,"type":21},"2026-09",{"name":152,"class":42},"McMaster University",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100624216","hemodynamic-venous-congestion-ultrasound-vexus-by-icu-nurses-in-sepsis-patients-100624216","NCT07406750","Hemodynamic Venous Congestion Ultrasound (VExUS) by ICU Nurses in Sepsis Patients.","Hemodynamic Diagnostic Ultrasound of Venous Congestion (VExUS) Performed by Intensive Care Nurses on Patients With Sepsis.","VEXIVAN","Inclusion Criteria:\n\nIntensive Care Nurses a) Intensive care nurse, specialist degree in intensive care. b) ≥1,5 years of experience in intensive care. c) ≥75% clinical employment rate at the ICU. d) Continued employment until 2026 at the ICU at Örebro University Hospital. e) Written informed consent Intensive Care Patients\n\n1. Patients with suspected or verified sepsis according to the Sepsis 3 criteria (suspected or confirmed infection), ≥qSOFA (systolic blood pressure \\\u003C 90 mmHg, GCS ≤ 13, respiratory rate ≥ 22 per minute) or rise in SOFA score ≥ 2 points and admitted to the ICU.\n2. ≥18 years of age.\n\nExclusion Criteria:\n\nIntensive Care Nurses\n\na) Personnel with primarily an administration position or less clinical duty at the ICU.\n\nIntensive Care Patients\n\n1. Patients with preexisting liver cirrhosis.\n2. Pregnancy.",true,{"count":163,"type":21},46,"Sepsis is a serious condition where the body's immune response to infection overreacts, leading to organ damage and death. Venous congestion, a buildup of blood in the veins, can occur in sepsis and contribute to organ injury. VExUS (Venous Excess Ultrasound Score) is an ultrasound method that can detect congestion early. This study examines whether ICU nurses, after training, can perform VExUS reliably, explores their experiences, and investigates links between VExUS findings and clinical outcomes.",[85,27,88,166],"Intensive Care Nurses",[168,169,170,171,172,173],"sepsis","intensive care","ultrasound","venous congestion","VExUS","intensive care nurse","2026-02-13",{"date":176,"type":35},"2026-02-18",{"date":96,"type":21},{"date":179,"type":21},"2027-05-31",{"name":181,"class":42},"Region Örebro County",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":161,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":191,"studyType":54,"phases":4,"briefSummary":192,"conditions":193,"keywords":199,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":43},"100578328","role-of-transposable-elements-in-septic-immune-aging-100578328","NCT06809868","Role of Transposable Elements in Septic Immune Aging","SITE","Inclusion Criteria:\n\n* Age 18 or older\n* Admitted to ICU with sepsis (Sepsis 3 Criteria)\n* SOFA score of at least 2 at time of enrollment\n\nExclusion Criteria:\n\n* Patients on organ transplantation immunosuppression\n* Patients with preexisting leukopenia\n* Cancer patients receiving CAR-T therapy\n* Patients who are under 18 years of age or otherwise deemed pediatric\n* Patients with an ongoing bleeding diathesis (ie: DIC, hemorrhagic shock)\n* Patients with a chronic hemoglobin below 7.0\n* Patients who, prior to their ICU admission, are blood transfusion dependent",{"count":190,"type":21},116,"6 Weeks","The goal of this observational study is to learn about how transposable element levels affect the patient outcomes in sepsis. The main questions it aims to answer is:\n\n1. Do transposable elements prematurely age the immune systems of patients with sepsis?\n2. Do transposable elements correlate with increased mortality in patients with sepsis in the ICU?\n3. Do transposable elements correlate with increased amount of secondary infections in patients with sepsis in the ICU?\n\nParticipants will have blood drawn from them but will not be subjected to additional interventions.",[85,27,194,195,196,88,197,198],"Sepsis With Multiple Organ Dysfunction (MOD)","Sepsis With Acute Organ Dysfunction","Sepsis, Severe","Sepsis, Severe Sepsis and Septic Shock","Sepsis, Septic Shock",[85,200,201,202,203,204],"Transposable Elements","Immune Aging","Mortality","Secondary Infections","Critical Care Medicine (ICU)","2026-01-28",{"date":207,"type":35},"2026-01-30",{"date":209,"type":35},"2025-02-14",{"date":211,"type":21},"2028-08-14",{"name":213,"class":42},"University of California, San Francisco",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":43},"100597792","phase-3-a-combination-therapy-with-ceftazidime-and-fosfomycin-will-be-compared-to-ceftazidime-alone-in-hospitalized-adult-patients-with-suspected-severe-gram-negative-bacterial-infections-100597792","NCT07063095","A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections","Ceftazidime Plus Fosfomycin Versus Ceftazidime Alone for Severe Gram-negative Infections: a Triple-blind, Placebo-controlled Point-of-care Randomized Clinical Trial","CAVIFOS","Inclusion Criteria:\n\n1. Adult (≥18 years)\n2. Hospitalized with suspected severe Gram-negative bacterial infection\n3. Signed informed consent from the patient (or oral consent from a patient with capacity but with physical inability to sign, with signed witness testimony from a person independent of the study team) of from the legal representative if the patient lacks capacity to provide informed consent\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Known contra-indication to CAZ±AVI or FOS\n3. Gram-negative directed antibiotic treatment begun \\>24 hours before inclusion",{"count":223,"type":21},100,[225],"PHASE3","The goal of this clinical trial is to :\n\n1. Test whether the combination of CAZ±AVI and FOS leads to superior clinical outcomes in patients with severe suspected Gram-negative bacterial infection, as demonstrated by a shorter time to normalization of quick Sequential Organ Failure Assessment (qSOFA) parameters and reduction in C-reactive protein (CRP) compared to standard of care (CAZ±AVI alone)\n2. to further characterize the safety profile of this combination therapy\n\nIn the presence of such an infection, standard treatment is to start intravenous antibiotic therapy. Ceftazidime (Fortam®), or ceftazidime-avibactam (Zavicefta®), is a standard antibiotic commonly used for this purpose (for very resistant bacteria, the compound avibactam is included to protect ceftazidime from being broken down by bacteria).\n\nResearchers will compare ceftazidime (or ceftazdime-avibactam) plus fosfomycin versus ceftazidime alone with placebo (i.e. a look-alike substance given with no drug) to examine whether the addition of another intravenous antibiotic, fosfomycin, would lead to faster recovery from severe infection and evaluate the tolerability of this combination.\n\nParticipants will:\n\n* Be randomly assigned to either the intervention group or the control group.\n* The intervention group will receive ceftazidime (with avibactam if multidrug resistant bacteria are suspected, per routine practice) and intravenous fosfomycin, and the control group will receive ceftazidime (with avibactam if multidrug resistant bacteria are suspected) and placebo.\n* Either treatment will be given for 3 days, three times daily (or less frequently, depending on renal function).\n* Provide a few extra blood samples (for CRP measurement, a protein marker of inflammation) during the first few days of the study.\n* Be contacted in the hospital or by phone if discharged on day 28 to be asked a few questions.",[228,27],"Gram Negative Infections",[230,231,232,233],"ceftazidime","cavifos","gram-negative bacteria","intravenous fosfomycin","2025-09-25",{"date":236,"type":35},"2025-09-26",{"date":238,"type":35},"2025-08-25",{"date":240,"type":21},"2026-12",{"name":242,"class":42},"Angela HUTTNER",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":161,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":252,"studyType":54,"phases":4,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":268,"locationsCount":270},"100568358","fibrinolysis-resistance-in-infection-and-trauma-100568358","NCT06680180","Fibrinolysis Resistance in Infection and Trauma","FORTITUDE","Sepsis\u002FSeptic shock Inclusion Criteria:\n\n* Admission to ICU, needing at least one organ supportand principally for the management of clinically suspected Sepsis or Septic shock according to Spesis-3 criteria (including SARS-COV-2)\n* Expected to remain in ICU and survive beyond the day after tomorrow\n\nSepsis Exclusion Criteria:\n\n* On oral anticoagulant\u002Fantiplatelet therapy\n* Not for full, active ICU support\n* Death is deemed inevitable within 24 hrs\n\nTrauma Inclusion Criteria:\n\n* Trauma is the principal diagnosis on ICU admission\n* Expected to remain in ICU and survive beyond the day after tomorrow\n* Receiving respiratory support at the time of ICU admission - high-flow nasal prongs, non-invasive or invasive ventilation\n* Already received, or considered at risk of needing a blood product transfusion within 24 hrs of injury\n\nTrauma Exclusion Criteria:\n\n* Nursing home resident\n* Unsurvivable head injury\n* Not for full, active ICU support\n* Death is deemed inevitable within 24 hrs",{"count":251,"type":21},150,"15 Days","Blood coagulation disorders are often seen in critically ill patients e.g. with severe infection or following extensive injury, that can lead to life threatening events as a result of excessive blood clot formation leading to organ failure. This study aims to use Viscoelastic Testing (VET) technology to detect patients at risk of excessive blood blot formation at the bedside, test new blood coagulation drugs, and guide life-saving use of blood modifying treatments.",[27,255],"Trauma",[257,85,255,258,259,260,261],"Viscoelastic testing (VET)","Fibrinolytic Agents","Fibrin Modulating Agents","Tissue Plasminogen Activator","Plasminogen","2024-11-06",{"date":264,"type":35},"2024-11-08",{"date":266,"type":35},"2024-06-01",{"date":63,"type":21},{"name":269,"class":42},"Anders Aneman",4]