[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593159":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":26,"responsibleParty":39,"collaborators":41,"id":44,"slug":10,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":10,"maxAge":52,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"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,"cosmosGeoPoint":33,"geoPoint":38,"contacts":10},"Hôpital Necker - Enfants Malades","RECRUITING","Paris","75015","France",{"type":34,"coordinates":35},"Point",[36,37],2.3488,48.85341,{"lat":37,"lon":36},{"type":40,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[42],{"name":43,"class":6},"URC-CIC Paris Descartes Necker Cochin","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":54,"type":55},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.",[59],"Allergy",[61,62,63,64],"Beta-lactams","Allerg","Allergology","Direct oral challenge","2026-04-30",{"date":67,"type":68},"2026-05-06","ACTUAL",{"date":70,"type":55},"2026-06",{"date":72,"type":55},"2027-06",{"name":5,"class":6},1]