[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593159":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":26,"responsibleParty":40,"collaborators":42,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":10,"maxAge":54,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Children requiring a direct oral challenge (DOC)",null,"Children previously labeled with suspected beta-lactam allergy, requiring a direct oral challenge (DOC) to confirm or rule out true hypersensitivity",[13],{"name":14,"affiliation":5,"role":15},"Sebastien LE, MD","PRINCIPAL_INVESTIGATOR",[17,22],{"name":14,"role":18,"phone":19,"phoneExt":20,"email":21},"CONTACT","06 35 14 12 41","+33","sebastien.le@aphp.fr",{"name":23,"role":18,"phone":24,"phoneExt":20,"email":25},"Gael Plastow","01 44 38 18 57","gael.plastow@aphp.fr",[27],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"Hôpital Necker - Enfants Malades","RECRUITING","Paris","75015","France","FR",{"type":35,"coordinates":36},"Point",[37,38],2.3488,48.85341,{"lat":38,"lon":37},{"type":41,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[43],{"name":44,"class":6},"URC-CIC Paris Descartes Necker Cochin","100593159","direct-oral-challenges-in-private-practice-setting-to-delabeling-children-with-beta-lactam-allergy-100593159",false,"NCT07002814","Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy","Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children","Betalactaville","Inclusion Criteria:\n\n* Population: Children's age between 0 and 17 years\n* Child who has undergone a direct oral challenge in a private medical practice and a follow-up consultation within 7 to 14 days for suspected delayed allergy to amoxicillin +\u002F- clavulanate or cefpodoxime or cefixime with the following characteristics:\n* delayed reaction (onset \\> 1 hour after treatment start),\n* mild reaction (isolated urticaria or Maculopapular exanthema),\n* Absence of warning signs suggestive of a severe cutaneous adverse reaction (erythroderma, presence of bullae, vesicles, pustules, target lesions, involvement of oral, genital, or ocular mucosa, facial edema, general condition impairment, organ failure, duration \\> 7 days).\n\nExclusion Criteria:\n\n* Informed children or holders of parental authority objecting to the use of patient data in the study.","ALL","17 Years",{"count":56,"type":57},200,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to demonstrate the feasibility of direct oral challenge performed in private practice setting for children with suspected benign delayed allergy to beta-lactams.\n\nThe results of this study could help establish recommendations for conducting direct oral challenge in primary care settings to delabeling children with benign delayed reactions to beta-lactams.",[61],"Allergy",[63,64,65,66],"Beta-lactams","Allerg","Allergology","Direct oral challenge","2026-04-30",{"date":69,"type":70},"2026-05-06","ACTUAL",{"date":72,"type":57},"2026-06",{"date":74,"type":57},"2027-06",{"name":5,"class":6},1]