[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-hypersensitivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-hypersensitivity":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100547295","phase-2-optimizing-the-diagnostic-approach-to-cephalosporin-allergy-testing-100547295",false,"NCT06406114","Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing","DACAT","Inclusion Criteria:\n\n1. Age 18-70 years old.\n2. Reaction history consistent with a potential immediate hypersensitivity reaction (pruritus, urticaria, erythema, angioedema, bronchospasm, wheezing, shortness of breath, anaphylaxis, or hypotension) to cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime.\n3. English speaking or non-English speaking with translation services available.\n\nExclusion Criteria:\n\n1. Severe concomitant medical condition (e.g., unstable coronary artery disease, congestive heart failure, severe chronic obstructive pulmonary disease, poorly controlled asthma, chronic renal failure, cirrhosis, or end-stage liver disease.)\n2. History of Clostridioides difficile infection\n3. Chronic spontaneous urticaria or systemic mastocytosis\n4. Incident reaction required cardiopulmonary resuscitation\n5. Reaction to 2 or more cephalosporin antibiotics\n6. Active infection or antibiotic treatment within 7 days\n7. Treatment with systemic antihistamines or corticosteroids within 7 days\n8. Treatment with omalizumab or dupilumab within 60 days\n9. Significant immunosuppression\n10. Treatment with a beta-blocker or ACE inhibitor within 7 days\n11. Use of investigational drugs within 60 days of participation\n12. Anaphylaxis in the last 30 days\n13. Penicillin anaphylaxis within the past year confirmed with positive penicillin skin tests\n14. Prison or jail inmates, pregnant women, severe cognitive impairment\n15. Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements\n16. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.\n17. Inability or unwillingness of a participant to give written informed consent or comply with study protocol","ALL","18 Years","70 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.",[27,28,29,30,31,32,33],"Drug Allergy","Cephalosporin Allergy","Drug Hypersensitivity","Antibiotic Allergy","Beta Lactam Adverse Reaction","Drug-Induced Anaphylaxis","Cephalosporin Reaction",[35,36,37,38,39,40,41,42,43,44],"Allergy","Antibiotic","Cephalosporin","Penicillin","Beta-lactam","Drug challenge","Skin testing","Adverse reaction","Anaphylaxis","Perioperative anaphylaxis","RECRUITING","2026-05-22",{"date":48,"type":49},"2026-05-26","ACTUAL",{"date":51,"type":49},"2025-05-05",{"date":53,"type":21},"2028-12-31",{"name":55,"class":56},"Massachusetts General Hospital","OTHER",6,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100387851","origin-and-function-of-eosinophilic-polynuclear-during-dress-syndrome-100387851","NCT04330118","Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome","Origin and Function of Eosinophilic Polynuclear During Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome","DRESSEO","Inclusion Criteria:\n\nGroup 1 (DRESS): adult with a diagnosis of DRESS based on the following four criteria:\n\n* Cutaneous rash occurring at least 24 hours and at most 2 months after continuous medication use\n* Fever over 38 degre celcius\n* At least one organ dysfunction among:\n* Lymphadenopathy\n* hepatitis\n* Pulmonary involvement\n* Cardiac involvement: myocarditis, pericarditis\n* Renal impairment\n* At least one of the following hematological anomalies:\n* Eosinophilia ≥ 500 \u002F mm3 .\n* RegiSCAR Score ≥ 4\n\nGroups 2 and 3 (Drug induced maculopapular exanthema without or with eosinophilia).\n\n* Adult with drug-induced rash\n* Without clinical criteria of severity defined by Djien among :\n* An evolution of more than 21 days\n* with organ damage as defined in group 1\n\nGroup 2 (MPE without eosinophilia): blood eosinophils \\\u003C 500 \u002F mm3\n\nGroup 3 (MPE with eosinophilia): blood eosinophils ≥ 500 \u002F mm3\n\nExclusion Criteria:\n\n* Other cause of eosinophilia including cancer, blood disease before the introduction of suspected molecule(s).\n* On going oral or local corticosteroid therapy, anti-leukotriene therapy (MONTELUKAST) by the month preceding the study;\n* Anti-IgE therapy (OMALIZUMAB, LIGELIZUMAB), anti-IL-5 therapy (MEPOLIZUMAB, BENRALIZUMAB) or anti-IL4 and \u002F or anti-IL13 therapy (DUPILUMAB, TRALOKINUMAB) in the 6 months preceding the study.\n* Any pregnant or lactating woman.\n* Contraindication related to the blood volume taken for the study.",true,{"count":68,"type":21},80,"OBSERVATIONAL","Drug Hypersensitivity Syndrome or DRESS for \"Drug Reaction with Eosinophilia and Systemic Symptoms\" is a serious drug allergy which can be life-threatening for patients with serious organ damage. The pathophysiology of DRESS is still not fully understood. In particular, no study has focused on the characterization of eosinophils, while paradoxically eosinophilia is one of the diagnostic criteria. Likewise, there is no data about the origin of eosinophils and few data are available concerning immune polarization of T-cells or the involvement of innate lymphoid cells type 2 in the recruitment of eosinophils. Our preliminary data on increase activation markers membrane expression of cutaneous eosinophils suggest that this approach could allow the identification of endotypes in which eosinophils are involved and contribute to organ damages. The correlation between tissue infiltration of eosinophils and their degree of activation would then justify the development of targeted therapeutic strategies in DRESS syndrome (anti-IL-5 therapy?). The aim of the project is: 1) Evaluate the activation status of circulating and cutaneous eosinophils in patients with DRESS compared with drug induced maculopapular exanthema without or with eosinophilia (but do not fulfill DRESS criteria) and healthy subjects; 2) Understand the pathophysiological mechanisms at the origin of this eosinophilia.",[29,72],"DRESS Syndrome",[74,75,76,77],"DRESS syndrome","Drug hypersensitivity","eosinophils","allergy","2026-04-21",{"date":80,"type":49},"2026-04-22",{"date":82,"type":49},"2020-07-15",{"date":84,"type":21},"2027-10",{"name":86,"class":56},"University Hospital, Lille",11,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":97,"studyType":69,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100622957","establishment-of-a-registry-for-immediate-drug-allergy-100622957","NCT07390370","Establishment of a Registry for Immediate Drug Allergy","Inclusion Criteria:\n\n1. Adult patients aged 19 years or older diagnosed with immediate hypersensitivity reactions (such as rash, urticaria, angioedema, anaphylaxis, etc.) within 1 hour after drug administration.\"\n2. Utilization of samples and clinical data from patients with immediate drug hypersensitivity who consented to participate in secondary research, registered in the study 'Establishment of a Registry for Identifying Factors Related to Diagnosis, Treatment, and Prognosis in Allergic Disease Patients' (Project Number 4-2013-0397).\n\nExclusion Criteria:\n\n1. Participants who do not consent to participate in the study.\"\n2. Children and adolescents under the age of 19.\"\n3. Participants who are unable to read or understand the consent form.\"","19 Years",{"count":96,"type":21},200,"4 Years","Immediate drug hypersensitivity reactions are acute adverse reactions that occur within one hour of drug administration and can result in life-threatening symptoms such as urticaria, angioedema, and anaphylaxis. Current diagnostic methods have high false-negative and false-positive rates, and standardized testing for non-IgE-mediated reactions (e.g., MRGPRX2) is lacking. This creates significant gaps in patient safety and clinical decision-making.\n\nThe study aims to establish a registry of patients with immediate drug hypersensitivity reactions to analyze clinical characteristics and investigate the underlying mechanisms of IgE-mediated and non-IgE-mediated reactions. Blood samples will be collected prospectively, using residual serum from routine clinical tests where available, to minimize additional blood draws. Mechanistic analyses will focus on IgE-mediated and non-IgE-mediated pathways, including MRGPRX2 expression in mast cells and basophils, and measurement of active β-tryptase as a biomarker for anaphylaxis.\n\nIn addition, a retrospective review will be conducted of medical records from the last 10 years to identify causative drugs and classify the underlying mechanisms of hypersensitivity. Based on this, specific target drugs will be selected for further prospective analysis. Data and biospecimens from participants in an existing allergy registry, who consent to secondary use, will also be included in the study.\n\nThrough the integration of clinical data and multi-layered biomarker analysis, the study aims to improve understanding of immediate drug hypersensitivity mechanisms and develop predictive models. Ultimately, this research will contribute to the establishment of personalized diagnosis, prevention, and treatment strategies for drug allergies.",[29],"NOT_YET_RECRUITING","2026-01-28",{"date":103,"type":49},"2026-02-05",{"date":105,"type":21},"2026-02-01",{"date":107,"type":21},"2030-12-31",{"name":109,"class":56},"Yonsei University"]