[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anakinra\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anakinra":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100564074","phase-4-immunomodulatory-effects-of-dexamethasone-tocilizumab-and-anakinra-during-experimental-human-endotoxemia-100564074",false,"NCT06624436","Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia","DEDICATE-LPS","Inclusion Criteria:\n\n* Male subjects aged ≥18 and ≤35 years\n* Body mass index (BMI) ≥18 and ≤30 kg\u002Fm2\n* Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters)\n* Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.\n\nExclusion Criteria:\n\n* Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs\n* Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients\n* History of chronic headache or previous post-dural puncture headache (PDPH)\n* History or signs of severe atopic syndrome (asthma, rhinitis with medication and\u002For eczema)\n* History of any disease associated with immune deficiency\n* History of cancer in the last 5 years (excluding localised skin cancer or carcinoma in situ)\n* History or signs of haematological disease\n* History or signs of thromboembolic disorders\n* History of peptic \u002F gastric ulcer disease\n* History of psychiatric disorders\n* Thrombocytopenia (\\<150\\*109\u002FmL) or anaemia (\\<8.0 mmol\u002FL)\n* History, signs or symptoms of cardiovascular disease, in particular:\n\n  * Prone to vagal collapse\n  * History of atrial or ventricular arrhythmia\n  * Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block\n  * Hypertension (defined as RR systolic \\> 160 or RR diastolic \\> 90 mmHg)\n  * Hypotension (defined as RR systolic \\< 100 or RR diastolic \\< 50 mmHg)\n* Renal impairment (defined as plasma creatinine \\>120 μmol\u002FL)\n* Liver enzyme abnormalities (above 2x the upper limit of normal)\n* Signs of infection (CRP \\> 20 mg\u002FL, white blood cells \\> 12x109\u002FL or\n\n  * lt; 4x109\u002FL)\n* Clinically significant acute illness, including infections or trauma, within 1 month prior to the first LPS challenge\n* Previous (participation in a study with) endotoxin (LPS) administration\n* Participation in an experimental intervention or drug trial within 3 months prior to the first LPS challenge\n* Any vaccination or blood donation within 1 month prior to the first LPS challenge\n* Recent hospital admission or surgery with general anaesthesia within 3 months prior to the first LPS challenge\n* Use of recreational drugs within 2 weeks prior to the first LPS challenge\n* Suspected of not being able to comply with the trial protocol\n* Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and\u002For take part in the study",true,"MALE","18 Years","35 Years",{"count":21,"type":22},52,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to investigate the immunomodulatory effects of the drugs dexamethasone, tocilizumab and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. The main questions it aims to answer are:\n\n* What are the effects of these drugs on the development of immunoparalysis in a repeated human endotoxemia model?\n* What is the extent of the neuroinflammatory response and how do these drugs affect neuroinflammation in a repeated human endotoxemia model?\n\nResearchers will compare these drugs to a placebo (a look-alike substance that contains no drug).\n\nParticipants will visit the Intensive Care research department on two or five occasions (screening included):\n\n* The intervention group will receive an LPS challenge twice, with a week in between. Before the first LPS challenge, one of the described drugs will be administered. Blood, saliva and tear fluid will be collected regularly during the LPS challenge. Cerebrospinal fluid will also be collected through a catheter in the spinal cord.\n* The control group will not receive an LPS challenge or drug administration and will have only one study day. During this day, blood, saliva, tear fluid and cerebrospinal fluid will be collected as regularly as during the LPS challenge of the intervention group.\n\nDuring an LPS challenge, the investigators mimic blood poisoning by giving an endotoxin, also called LPS. This is a small part of the cell wall of a bacteria. This will cause transient flu-like symptoms for 3-4 hours.",[28,29,30,31,32,33,34],"Sepsis","Neuroinflammatory Response","Immunosuppresion","Endotoxemia","Anakinra","Dexamethasone","Tocilizumab",[28,36,37,38,32,33,34,39,40,41],"Immunosuppression","Systemic inflammation","Neuroinflammation","Human endotoxemia","Immunoparalysis","Hyperinflammatory response","RECRUITING","2025-04-01",{"date":45,"type":46},"2025-04-04","ACTUAL",{"date":48,"type":46},"2024-10-24",{"date":50,"type":22},"2025-12",{"name":52,"class":53},"Radboud University Medical Center","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":68,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100569683","phase-4-non-inferiority-kawasaki-trial-with-anakinra-100569683","NCT06697431","Non Inferiority KawasakI Trial With Anakinra","A Randomized, Controlled, Open-label, Non Inferiority KawasakI Trial With Anakinra","NIKITA","Inclusion Criteria\n\n1. KD defined in at least one of the three following ways as per American Heart Association (AHA) criteria: Fever for at least 5 days in addition to 4 of the following 5 clinical criteria:\n\n   * bilateral non-purulent conjunctivitis\n   * cervical lymphadenopathy\n   * polymorphous skin rash\n   * changes in lips or mucosa (strawberry tongue, red cracked lips, diffuse erythematous oropharynx)\n   * extremity changes (erythema, oedema of palms and soles in initial phase, and at convalescent stage skin peeling)\n2. less than 5 days of fever but all 5 clinical criteria above\n3. incomplete KD cases defined as:\n\n   * children\u002Fadolescents (\\>1 year old) with fever greater than or equal to 5 days AND at least 2 other compatible clinical criteria as listed above;\n   * OR infants ≤ 1 year old with fever greater than or equal to 7 days without other explanation;\n\n   AND for both age groups, CRP ≥30 mg\u002FL or erythrocyte sedimentation rate (ESR) ≥40 mm\u002Fhr (or both) AND for both age groups EITHER the presence of any 3 or more of: anaemia for age (haemoglobin \\\u003C lower limit of normal reference range for local laboratory); platelet count ≥450,000\u002FL or \\\u003C140,000\u002FL; albumin \\\u003C30 g\u002FL; elevated ALT (\\> upper limit of normal reference range for local laboratory); white cell count ≥15,000\u002FL; urine ≥10 white blood cells per high power field iv.\n\n   OR abnormal echocardiogram compatible with KD but without established CAA, with ≥ 3 of the following suggestive features: decreased left ventricular function, mitral regurgitation, pericardial effusion, or dilated but non-aneurysmal coronary arteries (internal diameter 2≤Z\\\u003C2.5; and not meeting the exclusion criteria for aneurysmal change as defined below).\n4. To be enrolled children need to show persistent fever ≤7 days\n5. Written informed consent from an appropriate legal representative(s), and assent from patients older than 7 years\n\nExclusion Criteria\n\n1. Patients with KD and already established coronary artery aneurysms (CAA), as per AHA definition, at screening.\n2. Clinical picture consistent with Kawasaki Shock Syndrome (KDSS) or Macrophage Activation Syndrome (MAS) OR Multisystem Inflammatory Syndrome in Children (MIS-C)\n3. History or evidence of any previous heart disease\n4. Known hypersensitivity to anakinra, IVIG and ASA or any medical condition that contraindicates the use of these treatments\n5. Patients with KD receiving IVIG, corticosteroids, immunosuppressants, biologic treatments at the time of screening","ALL","1 Month","16 Years",{"count":67,"type":22},38,[25],"This is a multicenter, open-label, randomized, controlled, interventional trial followed by a long-term observational extension period in patients with Kawasaki Disease (KD) to be treated eitherwith endovenous Immunoglobulins (IVIG-standard treatment) versus anakinra\n\nAim of the study: to demonstrate that anakinra is non-inferior to IVIG in KD, in terms of fever control in the acute phase and development of coronary artery dilation\u002Faneurisms (CAA) within one year from the onset.",[71,32],"Kawasaki Disease","NOT_YET_RECRUITING","2024-11-19",{"date":75,"type":46},"2024-11-21",{"date":43,"type":22},{"date":78,"type":22},"2027-04-01",{"name":80,"class":53},"Meyer Children's Hospital IRCCS"]