[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemolytic-uremic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemolytic-uremic-syndrome":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100456094","hyperhydration-in-children-with-shiga-toxin-producing-e-coli-infection-100456094",false,"NCT05219110","Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection","Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial","HIKO-STEC","Inclusion Criteria:\n\nIn order to be eligible to participate in this study (i.e., to be enrolled in the relevant institutional clinical care pathway), an individual must meet all of the following criteria:\n\n1. Aged 9.0 months to \\\u003C21 years at the time of informed consent.\n2. Evidence of high-risk STEC infecting pathogen defined by any of the following:\n\n   1. Bloody diarrhea within the preceding 7 days\n\n      * Positive STEC culture OR\n      * Positive antigen\u002Fpolymerase chain reaction test for toxin\u002Fgene type not otherwise specified OR\n   2. Bloody or Non-bloody diarrhea within the preceding 7 days\n\n      •Presumptive diagnosis of HUS\n      * (meeting all 3 HUS criteria - anemia, thrombocytopenia, and renal insufficiency) OR\n   3. Non-bloody or no diarrhea\n\n      * Positive STEC culture for high-risk strain (i.e., O103, O104, O111, O113, O121, O145 or O157) OR\n      * Positive antigen\u002Fpolymerase chain reaction test Stx2 toxin\u002Fgene\n\nExclusion Criteria:\n\nAll individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.\n\n1. Presence of Advanced HUS defined by:\n\n   1. Hematocrit \\\u003C30% AND\n   2. Platelet count \\\u003C150 x 103\u002Fmm3 AND\n   3. Creatinine \\> 2.0 mg\u002FdL (177 µmol\u002FL)\n\n      * The presence of only 1 or 2 of these criteria will not result in patient exclusion, regardless of how close the 3rd criterion is to meeting the exclusion criteria.\n2. Prior episode of HUS or diagnosis of atypical HUS.\n3. Chronic disease limiting fluid volumes administered (e.g. impaired renal, liver, or cardiac function, chronic lung disease).\n4. Evidence of anuria (i.e., no urine output for \\> 24 hours).\n5. Hypoxemia requiring oxygen therapy\n6. Hypertensive emergency\n7. Greater than or equal to 10 days since onset of diarrhea or if no diarrhea then the onset of other symptoms.\n8. Patients with known pregnancy\n9. Patients or caregivers with language barriers impairing appropriate conduct of the study protocol.","ALL","9 Months","21 Years",{"count":21,"type":22},1040,"ESTIMATED","INTERVENTIONAL",[25],"NA","The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management).",[28,29],"Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection","Hemolytic-Uremic Syndrome",[31,32,33,34,35,36,37],"Child","Hemolytic Uremic Syndrome","Shiga-Toxigenic Escherichia coli","Renal Replacement Therapy","Acute Kidney Injury","Ambulatory Care","Emergency Department","RECRUITING","2026-05-13",{"date":41,"type":42},"2026-05-18","ACTUAL",{"date":44,"type":42},"2022-09-29",{"date":46,"type":22},"2028-08-31",{"name":48,"class":49},"University of Calgary","OTHER",26,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100546018","phase-3-efficacy-of-inm004-in-children-with-stec-hus-100546018","NCT06389474","Efficacy of INM004 in Children With STEC-HUS","A Phase III Study to Evaluate the Efficacy of INM004 (Shiga Antitoxin) in Pediatric Patients With Shiga Toxin-producing Escherichia Coli-associated Hemolytic Uremic Syndrome.","Inclusion Criteria:\n\n1. Age ≥ 9 months and \\\u003C 18 years at the time of randomization.\n2. In addition, only for subjects \\\u003C 1 year and ≥ 15 years, confirmation of STEC infection determined by:\n\n   1. Detection of generic Stx, Stx1, Stx2, or Stx1\u002FStx2 in stools by enzyme immunoassay (EIA); or\n   2. Detection of stx, stx1, stx2, or stx1\u002Fstx2 genes in stools by Polymerase Chain Reaction (PCR); or\n   3. Detection of specific anti-polysaccharide (IgM) antibodies in serum; or\n   4. Fecal culture positive for E. coli O157 confirmed by serogroup-specific seroagglutination.\n3. Hospitalization at the participating institution.\n4. History of onset of diarrhea within 10 days prior to STEC-HUS diagnosis at the participating institution.\n5. Diagnosis of STEC-HUS defined as a subject with signs of renal damage, hemolysis, and platelet consumption:\n\n   1. Signs of renal damage defined as:\n\n      * Serum creatinine value above the ULN for age and sex, and GFR below the LLN for age, sex, and height.\n   2. Presence of hemolysis documented by:\n\n      * LDH levels above the ULN for age, and\u002For\n      * Presence of schistocytes in peripheral blood smear.\n   3. Platelet consumption according to any of the following laboratory criteria:\n\n      * Peripheral blood platelet count \\\u003C 150 × 103\u002FμL, and\u002For\n      * A ≥50% decrease in peripheral blood platelet count compared to a sample collected within the previous 24 hours.\n6. Informed consent form signed and dated by the subject or, the legal guardian(s), with the subject's assent as appropriate based on age and regulatory guidelines in the region.\n7. Subjects who have already had menarche must have a negative pregnancy test.\n\nExclusion Criteria:\n\n1. Start of dialysis within 48 hours prior to admission to the participating institution.\n2. More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.\n3. History of chronic\u002Frecurrent hemolytic anemia, thrombocytopenia, or CKD.\n4. Personal and\u002For family history of atypical HUS.\n5. Suspected HUS secondary to infectious processes other than gastrointestinal (e.g., Streptococcus pneumoniae, HIV).\n6. Suspected HUS secondary to other etiologies (e.g., drug-associated HUS, neoplasms, bone marrow or solid organ transplantation, autoimmune disorders).\n7. Any other acute or chronic medical condition that, in the opinion of the investigator, may interfere with the evaluation of the efficacy and\u002For safety of the study medication.\n8. History of: a) anaphylaxis of any kind; b) prior administration of equine serum (e.g., antivenom, anti-arachnid serum, anti-SARS-CoV-2 serum, etc.) or an allergic reaction from contact or exposure to horses.\n9. Pregnant or breastfeeding woman.\n10. Impossibility of hospitalization in the participating institution.\n11. Concurrent participation in another clinical trial or having participated in a clinical trial in the last 3 months.\n12. Severe malnutrition. Defined when the weight is three standard deviations below the median, according to height, age and sex as per WHO guidelines.\n13. Medical conditions that may affect kidney function or cause\u002Fenhance neurological symptoms or signs:\n\n    * Congenital or acquired anomalies that may affect functioning renal mass.\n    * Epilepsy or structural abnormalities of the brain that may increase the risk of seizures.\n    * Trisomy 21.\n    * Prematurity (born before 28 weeks gestation).\n    * Other (according to investigator criteria).","17 Years",{"count":60,"type":22},220,[62],"PHASE3","The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS).",[29],[66,67,68,69,70],"STEC-HUS","Typical Hemolytic Uremic Syndrome","Diarrhea asociated-Hemolytic Uremic Syndrome","Shiga toxin-producing Escherichia coli","Shiga toxin","2026-01-13",{"date":73,"type":42},"2026-01-15",{"date":75,"type":42},"2024-10-05",{"date":77,"type":22},"2026-12-31",{"name":79,"class":49},"Inmunova S.A.",52,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":92,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":106},"100419705","complement-prospective-evaluation-of-thrombotic-microangiopathy-on-endothelium-100419705","NCT04745195","Complement Prospective Evaluation of Thrombotic Microangiopathy on Endothelium","Diagnostic and Risk Criteria for Complement Defects in Thrombotic Microangiopathy and Amplifying Conditions, Such as Severe Hypertension: The COMPETE Study.","COMPETE","Inclusion Criteria:\n\n* Males or females at least 18 years of age;\n* Have acute kidney injury, defined as estimated GFR \\\u003C45 mL\u002Fmin\u002F1.73m2;\n* Have documented TMA either on peripheral blood, defined as Coombs negative microangiopathic hemolytic anemia (hematocrit \\\u003C30%, hemoglobin \\\u003C6.5 mmol\u002FL \\[\\\u003C10 g\u002FdL\\], lactate dehydrogenase \\>500 U\u002FL, and either schistocytes on peripheral blood smear or undetectable haptoglobin), and platelets \\\u003C150,000 per µL, or kidney biopsy;\n* Have primary atypical HUS or a coexisting condition linked to complement dysregulation:\n\n  * Hypertensive emergency, defined as SBP\u002FDBP of \\>180\u002F120 mmHg and impending organ damage secondary to hypertension (at least one of the following: neurologic disease, hypertensive retinopathy grade III and\u002For IV, left ventricular hypertrophy); OR\n  * Pregnancy, including 12 weeks postpartum; OR\n  * Kidney donor recipient; OR\n  * Systemic auto-immune disease associated with TMA, including systemic sclerosis, systemic lupus erythematosus, anti-phospholipid syndrome;\n* Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.\n\nExclusion Criteria:\n\n* Have secondary causes of hypertensive emergency, including renovascular hypertension, Cushing syndrome, aldosteronism, pheochromocytoma, thyroid disease;\n* Have a nephropathy not related to thrombosis on kidney biopsy;\n* Have ADAMTS13 deficiency, defined as ADAMTS13 activity \\\u003C10%;\n* Have a positive stool culture for Shiga toxin producing bacteria;\n* Have positive serologic test for viral infections, including HIV and CMV;\n* Have a history of malignant disease, excluding non-melanoma skin cancer;\n* Have a history of bone marrow or solid organ transplantation, excluding kidney transplantation;\n* Received at least one of the following agents: chemotherapeutics, sirolimus, anti-VEGF agents;\n* Have a history of recent past exposure to illicit drug(s).","18 Years",{"count":91,"type":22},42,"12 Months","OBSERVATIONAL","Thrombotic microangiopathy (TMA) is a severe and life-threatening condition, often affecting the kidneys and brain. It can occur on the background of various clinical conditions. Dysregulation of the alternative pathway of complement may be the etiological factor and this type of TMA is classified, according to the current nomenclature, as primary atypical hemolytic uremic syndrome (HUS). Half the patients with primary atypical HUS present with rare variants in complement genes, although coexisting conditions are often needed for the TMA to become manifest. In patients with secondary atypical HUS, certain coexisting conditions appear to drive the disease and treatment should target the underlying condition to remit the TMA.\n\nRecently, the investigators demonstrated, by using a novel in-house developed functional endothelial cell-based test, that complement dysregulation and overactivation is the dominant cause of disease and its sequelae in a subset of patients with secondary atypical HUS, having impact on treatment and prognosis. The investigators did first prove this concept in patients presenting with TMA and hypertensive emergency. A prospective study is needed to further corroborate these findings along the spectrum of TMA. The investigators hypothesize that their functional endothelial cell-based test, the so-called \"HMEC\" test, can better categorizes the TMA into different groups with potential therapeutic and prognostic implications. Thus, paving the road to the ultimate goal of precision medicine.",[96,97,29],"Thrombotic Microangiopathies","Hemolytic Uremic Syndrome, Atypical","2025-09-25",{"date":100,"type":42},"2025-10-01",{"date":102,"type":42},"2021-08-11",{"date":77,"type":22},{"name":105,"class":49},"Maastricht University Medical Center",1]