[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"penicillin-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:penicillin-allergy":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,68,96,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100602770","provocation-after-nurse-directed-assessment-panda-study-100602770",false,"NCT07127835","Provocation After Nurse-Directed Assessment (PANDA) Study","PANDAS","Inclusion Criteria:\n\n* Receiving inpatient or outpatient treatment at a participating hospital during the study period;\n* Possessing a documented penicillin allergy label;\n* Underwent penicillin allergy evaluation by the nurse-allergist collaborative approach or the traditional allergist-led approach\n* Demographic and clinical data required for the study available.\n\nExclusion Criteria:\n\n* Patients unable to provide a complete medication history or history of penicillin allergy;\n* Patients with only emergency or short-term treatment records;\n* Patients who have taken steroids, antihistamines, or similar medications within the last 3 days.","ALL","18 Years",{"count":19,"type":20},440,"ESTIMATED","OBSERVATIONAL","The study aims to evaluate the effectiveness and safety of a collaborative nurse-allergist approach in penicillin allergy delabeling services. It also seeks to assess the impact on patients' quality of life and compare resource utilization and cost-effectiveness between the nurse-allergist collaborative approach and the traditional allergist-led approach.",[24,25],"Drug Allergy","Penicillin Allergy",[27,28,29],"Nurse-led Service","Drug Provocation Test","Delabelling","RECRUITING","2026-04-28",{"date":33,"type":34},"2026-04-29","ACTUAL",{"date":36,"type":34},"2025-09-01",{"date":38,"type":20},"2029-08-31",{"name":40,"class":41},"The University of Hong Kong","OTHER",4,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100474954","early-phase-1-geisinger-antibiotic-allergy-pilot-program-assess-and-address-100474954","NCT05464615","Geisinger Antibiotic Allergy Pilot Program: Assess and Address","Geisinger Antibiotic Allergy Pilot Program: Assess and Address (GAAP) Penicillin Allergy De-labeling in Inpatient Setting by Performing Direct Oral Amoxicillin Challenge in Low-risk Patients","GAAP","Inclusion Criteria:\n\n* Hospitalized male or female patients with a history of Penicillin (PCN) allergy or PCN-derivative allergy as reported by patient or documented in Epic\n* ≥18 years of age\n* Patients with a medical need for treatment with a PCN or PCN-derivative or other beta-lactam antibiotics as determined by an inpatient provider\n* Able and willing to provide consent in English.\n\nExclusion Criteria:\n\n* History of documented immediate-onset severe allergic reaction or delayed onset hypersensitivity reaction to a PCN or PCN-derivative\n* Patients who are hemodynamically unstable (e.g., pulse oximetry O2 saturation \\\u003C90 %, respiratory rate \\>=21 per minute, severe hypoxia requiring non-invasive ventilation, high-flow nasal canula, or mechanical ventilation, refractory hypotension requiring vasopressor support, heart rate \\>100 beats per minute, etc.)\n* Patients with uncontrolled pulmonary diseases (like exacerbation of asthma, Chronic Obstructive Pulmonary Disease (COPD), and\u002For other forms of chronic lung diseases)",{"count":52,"type":20},100,"INTERVENTIONAL",[55],"EARLY_PHASE1","This is a prospective non-inferiority study to evaluate penicillin allergy history in patients with reported penicillin allergy, who require penicillin or penicillin-derivative antibiotic during inpatient admission using a focused questionnaire. A simplified scoring system will be assigned to patient responses, and the total score will be utilized to identify low-risk patients that have a minimal risk of allergic reactions on exposure to penicillin or its derivative. Patients determined to have low risk based on this questionnaire will be offered a test dose (graded challenge) of amoxicillin in a supervised setting, and if they tolerate it, penicillin allergy label will be removed from patient's chart. We hypothesize that at least 95% of low-risk patients will successfully pass the graded amoxicillin challenge so the penicillin allergy label can be removed from their charts. A proportion as low as 0.85 would be a good clinical outcome and considered non-inferior to the expected proportion of 0.95.",[25],"2025-08-18",{"date":60,"type":34},"2025-08-22",{"date":62,"type":34},"2024-03-04",{"date":64,"type":20},"2025-12-31",{"name":66,"class":41},"Geisinger Clinic",3,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":53,"phases":77,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100539383","phase-3-penicillin-allergy-delabeling-after-a-one-dose-versus-two-dose-graded-direct-oral-challenge-100539383","NCT06303128","Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge","Inclusion Criteria:\n\n* Expresses interest in participating by calling or filling out information form on study website\n* Reports an allergy to one of the following medications: penicillin VK, penicillin G, amoxicillin, ampicillin, dicloxacillin, flucloxacillin, nafcillin, oxacillin, amoxicillin- clavulanate, ampicillin-sulbactam. Subjects with an unspecified penicillin allergy are also eligible to participate.\n\nExclusion Criteria:\n\n* Penicillin allergy deemed to be more than \"low-risk\" per PEN-FAST (score ≥ 3 points)\n* History of acute kidney injury (acute interstitial nephritis), severe liver impairment (drug- induced liver injury), serum sickness, or isolated drug fever attributed to a penicillin- based antibiotic\n* Anaphylaxis for any reason in the last year\n* Cognitive impairment where a collateral history could not be obtained and\u002For patient does not have capacity to consent for themselves\n* Pregnant (self-reported)\n* Any illness or condition that would increase the risk of participation in the study, per the evaluating clinician's judgment\n* Active treatment of or history of acute angle closure glaucoma\n* On H1- or H2-blockers (i.e. diphenhydramine, hydroxyzine, chlorpheniramine, cetirizine, levocetirizine, loratadine, fexofenadine or famotidine, ranitidine, cimetidine, nizatidine, respectively) within 72 hours of initiating direct oral challenge (will be counseled to discontinue prior to testing)\n* Actively receiving greater than stress dose steroid (hydrocortisone \\>50mg four times a day or steroid equivalent)\n* Actively receiving any antibiotic\n* Relative contraindication: Patients on beta blockers and angiotensin converting enzyme inhibitors (ACE inhibitors) will have an open dialog with the study team regarding the risks and benefits of testing a low-risk penicillin allergy patient. A joint decision will be made based on the patient's preference and the physician's comfort level.","89 Years",{"count":76,"type":20},380,[78],"PHASE3","The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as \"penicillin-allergic\" previously. The main question it aims to answer is:\n\n\\- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?\n\nParticipants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction.",[25],[82,83,84,85],"low-risk allergy","amoxicillin","drug allergy","direct oral challenge","2025-04-28",{"date":88,"type":34},"2025-05-01",{"date":90,"type":34},"2024-02-03",{"date":92,"type":20},"2026-12",{"name":94,"class":41},"James Tarbox, MD",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":53,"phases":103,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100574130","risk-stratified-testing-for-safe-removal-of-penicillin-allergy-labels-100574130","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",{"count":52,"type":20},[104],"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.",[25,107,108,109],"Hypersensitivity, Immediate","Hypersensitivity, Delayed","Hypersensitivity Response",[111,112,113],"PEN-FAST","penicillin allergy","allergy delabeling","2025-04-09",{"date":116,"type":34},"2025-04-10",{"date":118,"type":34},"2025-01-08",{"date":120,"type":20},"2027-02",{"name":122,"class":41},"Deniz Göcebe",2,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":53,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100557002","evaluating-the-feasibility-of-high-volume-low-risk-penicillin-allergy-de-labelling-to-maximise-efficiency-in-a-resource-limited-setting-100557002","NCT06532448","Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting","De-Label Me","Inclusion Criteria:\n\n1. Penicillin allergy label\n2. Age ≥18\n3. Registered as a patient with University Hospital Southampton NHS Foundation Trust (with a UHS medical record)\n4. Able and willing to consent to penicillin de-labelling\n\nExclusion Criteria:\n\n1. Penicillin allergy previously confirmed via positive blood, skin, BAT or challenge testing\n2. PEN-FAST score \\>2 (indicating a moderate or high risk of a positive challenge)\n3. Anaphylaxis, angioedema, wheeze, shortness of breath or suspected hypotension linked to treatment with penicillin\n4. Received treatment in hospital for a reaction linked to penicillin (unless already an inpatient at onset)\n5. Itchy or urticarial rash within 1 hour of starting a new course of treatment with penicillin\n6. Severe cutaneous adverse reaction (SCAR) linked to penicillin exposure (e.g. SJS\u002FTEN, DRESS), including symptoms suggestive of SCAR without a formal diagnosis (e.g. skin blistering or peeling, mucosal involvement)\n7. History of other serious, non-immediate reactions linked to penicillin (e.g. haemolytic anaemia, transaminitis, nephritis)\n8. Currently pregnant or breastfeeding\n9. Poorly controlled asthma\n10. Severe COPD\n11. Severe or critical aortic stenosis\n12. Clinically unstable secondary to other organ failure\n13. Unwell or unstable on the day of proposed penicillin challenge (including acute febrile illness)\n14. Prescribed other antibiotics on the day of proposed challenge, unless taken as a long-term treatment\u002Fprophylaxis",true,{"count":133,"type":20},36,[104],"Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling, but few have addressed how to organise de-labelling at the clinic level. This study will test the real world practicalities of running a de-labelling clinic optimised for maximum patient volume. The sheer number of patients with a penicillin allergy label, in contrast to relatively few allergy centres, makes demonstrating that such an approach can work extremely important for future antimicrobial stewardship.",[25],"NOT_YET_RECRUITING","2024-08-01",{"date":140,"type":34},"2024-08-05",{"date":142,"type":20},"2024-10",{"date":144,"type":20},"2025-10",{"name":146,"class":41},"University Hospital Southampton NHS Foundation Trust"]