[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659654":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":31,"armGroups":39,"interventions":45,"overallOfficials":49,"centralContacts":53,"locations":31,"responsibleParty":62,"collaborators":31,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":87,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":31},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":31},[9,13,16,20,24,28],{"measure":10,"description":11,"timeFrame":12},"Proportion of consented participants who are eligible for the Ultra-Rush Day","72% is defined as successful. This outcome will determine the feasibility of recruitment.","Day 1",{"measure":14,"description":15,"timeFrame":12},"Proportion of participants who complete the Ultra-Rush Day schedule according to the protocol","72% is defined as successful. This outcome will determine the feasibility of the protocol.",{"measure":17,"description":18,"timeFrame":19},"Proportion of participants who complete the Build-Up schedule according to the protocol","72% is defined as successful.","Week 2 through to Week 16",{"measure":21,"description":22,"timeFrame":23},"Proportion of participants who complete the Ultra-Rush Day (Day 1) to the post-treatment visit done 8 weeks after ceasing treatment","72% is defined as successful","Day1 through to Month 14",{"measure":25,"description":26,"timeFrame":27},"Proportion of participants with a treatment-related unexpected serious adverse event","This outcome will allow assessment of the safety of the intervention","Day 1 through to Month 12",{"measure":29,"description":30,"timeFrame":27},"Proportion of participants who discontinue due to adverse events","This will allow assessment of the safety of the intervention",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE","This is a prospective, single-arm, open-label pilot clinical trial evaluating a remission-focused rapid escalation, high-dose oral immunotherapy (OIT) protocol designed to induce clinical remission in children aged 1-5 years with challenge-confirmed cashew allergy.\n\nTrial population: 25 participants ages 1-5 years with current cashew allergy confirmed by a failed cashew oral food challenge (OFC) and a positive cashew SPT or sIgE level at screening.\n\nStudy duration per participant \\~ 17 months. Participants will receive cashew OIT daily for 12 months. Study phases include: Initial treatment day, build-up phase, maintenance (until 12 months of treatment is completed) and then elimination phase (OFC will be performed after treatment completion and 8 weeks after end-of-treatment).",[40],{"label":41,"type":6,"description":42,"interventionNames":43},"cashew oral immunotherapy","open label pilot study",[44],"Other: cashew oral immunotherapy",[46],{"type":6,"name":41,"description":47,"armGroupLabels":48,"otherNames":31},"Enrolled participants will receive cashew immunotherapy daily for 12 months",[41],[50],{"name":51,"affiliation":5,"role":52},"Mimi Tang, Prof","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":31,"email":58},"Adriana Chebar Lozinsky Rolnik","CONTACT","+61399366435","cashew.study@mcri.edu.au",{"name":60,"role":56,"phone":61,"phoneExt":31,"email":31},"Amanda Burgess","+61383416200",{"type":63,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100659654","rapid-escalation-oral-immunotherapy-to-achieve-remission-in-children-with-cashew-allergy-100659654",false,"NCT07868731","Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew Allergy","REACH-Cashew: Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew","REACH-Cashew","Inclusion Criteria:\n\n* Age between 1 year and 5 years\n* \\>7kg (the weight considered safe for the administration of an adrenaline device)\n* Cashew allergy confirmed by failed cashew oral food challenge (OFC) AND positive cashew skin prick test (SPT) or specific Immunoglobulin E (sIgE) at screening\n* Has a legal representative capable of understanding the informed consent document and providing consent on the participant's behalf\n\nExclusion Criteria:\n\n* History of severe anaphylaxis to cashew (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)\n* Severe anaphylaxis during the study entry challenge (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)\n* Ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)\n* Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis\n* History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)\n* Current use of beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, cardiovascular disease or ongoing chronic persistent asthma that increase the risks associated with anaphylaxis\n* Have received other food immunotherapy treatment in the preceding 12 months or currently taking immunomodulatory therapy (including allergen immunotherapy)\n* Currently taking immunomodulatory therapy (including allergen immunotherapy)\n* Past or current major illness that in the opinion of the Principal Investigator may affect the participant's ability to participate in the study e.g. increased risk to the participant\n* Participants who in the opinion of the Principal Investigator are unable to follow the protocol\n* Another family member already enrolled in the trial (to maintain safety and equity of access)","ALL","1 Year","5 Years",{"count":76,"type":77},25,"ESTIMATED","INTERVENTIONAL",[33],"Children with cashew allergy have no approved treatment and must rely on lifelong avoidance, which is stressful and often fails. Less than 10% outgrow their allergy. Cashew is a leading cause of severe reactions in young children. Oral immunotherapy (OIT) can induce remission in peanut allergy, allowing children to eat peanut safely, but this has not been tested for cashew. This study will assess whether cashew OIT can safely achieve remission and improve quality of life.",[82],"Food Allergy in Children",[84,85,86],"oral immunotherapy","food allergy","paediatrics","NOT_YET_RECRUITING","2026-10-05",{"date":90,"type":91},"2026-10-09","ACTUAL",{"date":93,"type":77},"2026-10",{"date":95,"type":77},"2029-10",{"name":5,"class":6}]