[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574130":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":29,"locations":38,"responsibleParty":69,"collaborators":11,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":74,"sex":78,"minAge":79,"maxAge":11,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University Hospital Heidelberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Direct drug provocation test","EXPERIMENTAL",null,[13],"Other: Direct Oral challenge",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","ACTIVE_COMPARATOR","Standard of care Skin testing and measurement of allergen-specific IgE, if negative, drug provocation test.",[19],"Other: standard of care",[21,25],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"Direct Oral challenge","Patients will receive a 1-step or 2-step challenge with the suspected penicillin and will be monitored for any allergic reaction within the first four hours. Patients will be instructed to contact the hospital after the drug provocation test to inquire delayed allergic reactions.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"standard of care","The patient will receive skin prick test and patch test (if a delayed allergy is suspected). Allergen-specific IgE will be measured. If all negative, drug provocation tets will be performed identical to the experimental group.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Deniz Göcebe, MD","CONTACT","+4962215639539","Deniz.Goecebe@med.uni-heidelberg.de",{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},"Knut Schäkel, MD","Knut.Schaekel@med.uni-heidelberg.de",[39,58],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University Hospital Heidelberg, Dermatology","RECRUITING","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],8.69079,49.40768,{"lat":51,"lon":50},[54,55],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"name":56,"role":57,"phone":11,"phoneExt":11,"email":11},"Deniz Göcebe","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine",{"type":48,"coordinates":61},[50,51],{"lat":51,"lon":50},[64,68],{"name":65,"role":32,"phone":66,"phoneExt":11,"email":67},"Elham Khatamzas, MD","+4962215622999","Elham.Khatamzas@med.uni-heidelberg.de",{"name":65,"role":57,"phone":11,"phoneExt":11,"email":11},{"type":70,"investigatorFullName":56,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Dr. med. Deniz Göcebe","100574130","risk-stratified-testing-for-safe-removal-of-penicillin-allergy-labels-100574130",false,"NCT06755281","Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels","Inclusion Criteria:\n\n1. Adult outpatients or inpatients with a penicillin allergy label\n2. Willing and able to give consent.\n3. PEN-FAST score of 0-2 points\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent\n3. Concurrent antihistamine therapy\n4. Pregnancy\n5. Significantly impaired general condition\n6. Unstable or therapeutically inadequately controlled bronchial asthma\n7. History of stem cell transplantation\n8. History of acute interstitial nephritis\n9. Chronic urticaria\n10. Mastocytosis","ALL","18 Years",{"count":81,"type":82},100,"ESTIMATED","INTERVENTIONAL",[85],"NA","The aim of this clinical trial is to analyze the negative predictive capacity and safety of risk-stratified direct drug provocation tests for patients with self-reported penicillin allergies. Patients reporting immediate or delayed penicillin allergies and defined as low-risk by the PEN-FAST score will receive drug provocation tests without prior skin testing.",[88,89,90,91],"Penicillin Allergy","Hypersensitivity, Immediate","Hypersensitivity, Delayed","Hypersensitivity Response",[93,94,95],"PEN-FAST","penicillin allergy","allergy delabeling","2025-04-09",{"date":98,"type":99},"2025-04-10","ACTUAL",{"date":101,"type":99},"2025-01-08",{"date":103,"type":82},"2027-02",{"name":56,"class":6},2]