[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antibiotic-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antibiotic-allergy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,91],{"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":22,"phases":69,"briefSummary":71,"conditions":72,"keywords":73,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100575373","support-tool-for-antibiotic-allergy-delabeling-100575373","NCT06771440","Support Tool for Antibiotic Allergy deLabeling","Impact Assessment of a Clinical Decision Support Tool for Non-invasive Antibiotic Allergy Label Delabeling and Refinement","STAAL","Inclusion Criteria:\n\n1. Hospitalized patients\n2. AAL for one or more beta-lactams\n\nExclusion Criteria:\n\n1. Age younger than 18\n2. Previous enrolment in this study",true,{"count":68,"type":21},3000,[70],"NA","Antibiotic allergy labels (AAL) are reported in 7% of inpatient's charts, especially for beta-lactams (86% of AAL, i.e., prevalence of 6%). They are associated with increased length of hospital stay, and use of second-line and broad-spectrum antibiotics. Allergy workups are able to invalidate the majority of these AAL but are time-consuming and require invasive skin and provocation testing. The investigators recently evaluated, for the first time in Europa, a strictly non-invasive delabeling protocol using a questionnaire, medical file search and contact with primary care health care workers in 200 adult internal medicine inpatients with a beta-lactam AAL. Up to half of the AAL could be removed or refined, demonstrating the potential of this strategy. In this project, they aim to assess the impact of using the non-invasive 'AAL-fact-check' tool in a multicenter study, on antibiotic selection, and clinical, antimicrobial, and economic endpoints, as compared with the standard of care (i.e., no AAL-fact-check tool).",[30],[74,75,76,77,78,79,80],"Penicillin allergy","Delabeling","beta-lactam","electronic health records","clinical decision support","Antibiotic allergy","drug allergy","2025-12-15",{"date":83,"type":49},"2025-12-16",{"date":85,"type":49},"2025-03-10",{"date":87,"type":21},"2026-05",{"name":89,"class":56},"Universitaire Ziekenhuizen KU Leuven",1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":90},"100471596","repertoire-and-properties-of-anti-drug-antibodies-involved-in-immediate-hypersensitivity-in-the-operating-room-100471596","NCT05420935","Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room","MEDIREP","Inclusion Criteria:\n\nCommon to both groups:\n\n* Age ≥ 18 years old and ≤ 70 years old\n* Patient having presented an allergic reaction in the operating room in the last 10 years, regardless of the grade of severity, the causative agent or the type of anesthesia\n* Patient having benefited from an allergy-anaesthesia consultation in the investigator center\n\nFor IgE group:\n\n\\- presence of at least one positive skin test to one of the suspected agent (curare and\u002For antibiotic) during the allergist consultation\n\nFor the IgG group:\n\n\\- presence of circulating IgG-type antibodies directed against one of the suspected agents (curare, antibiotic, antiseptic), identified in the routine biological tests carried out at the time of the shock and \u002F or the consultation of allergology.\n\nExclusion Criteria:\n\nCommon to both groups:\n\n* Absence of written informed consent\n* Protected person: under guardianship or curatorship\n* Patient without social security\n* Pregnancy of breast feeding\n* Ongoing immunosuppressive or chemotherapy\n* Acute heart failure\n* Patient included in another interventional research with an exclusion period\n\nFor IgE group:\n\n* Taking oral or injectable anticoagulants\n* Taking a double antiplatelet aggregation\n* Previous sternotomy\n* Previous thoracic radiation therapy\n* Known allergy to local anesthesic or iodinated skin products\n* Previous major sternal cutaneous lesions\n\nPrerequisites for carrying out the sternal sample in order to carry out a myelogram (IgE group):\n\n* Leukocytes \\> 4 giga\u002FL in the 2 months preceding inclusion\n* Platelets \\> 100,000 \u002F mm3 in the 2 months preceding inclusion\n\nFor the IgG group\n\n* Orthostatic hypotension\n* Realization of a blood donation in the 6 to 8 weeks preceding inclusion\n\nPrerequisites for performing the blood sample (IgG group):\n\n\\- Hemoglobin \\> 12.5 g\u002FdL for women and \\> 13 g\u002FdL for men in the 2 months preceding inclusion",{"count":99,"type":21},40,[70],"Acute per-anesthetic hypersensitivity reaction (HSA-PA) is a rapidly occurring systemic reaction following injection of a drug during anesthesia (mortality between 3 and 9%). The substances responsible for these reactions in France are curare in 60% of cases, followed by antibiotics. The main mechanism mentioned is an immediate systemic hypersensitivity immune reaction mediated by IgE antibodies (anaphylaxis). NeuroMuscular Blocking Agents (NMBA; curare) relax skeletal muscles to facilitate surgeries and permit intubation, but lead to adverse reactions: (a) severe hypersensitivity reactions (anaphylaxis) thought to rely on pre-existing anti-NMBA antibodies; (b) complications due to postoperative residual curarization. Identification of patients at risk remains suboptimal due to the lack of adequate tools to detect anti-NMBA antibodies. A capturing agent exists for only one out of the four most used NMBAs, allowing reversal of profound curarization. Case reports suggested that it might also ameliorate an ongoing anaphylaxis due to that NMBA.\n\nBased on strong preliminary results, our study proposes to characterize anti-drugs antibody repertoires in patients with various NMBA or antibiotics-anaphylaxis, describe activation pathways leading to anaphylaxis, develop and validate diagnostic and therapeutic molecules to ameliorate patient screening, NMBA-anaphylaxis and reverse profound neuromuscular block.",[103,104,30,105],"Hypersensitivity, Immediate","Peri-operative Injury","Antibody Hypersensitivity",[107],"Hypersensitivity, IgE, IgG, repertoire, NMBA, anaphylaxis","2024-09-02",{"date":110,"type":49},"2024-09-19",{"date":112,"type":49},"2023-04-12",{"date":114,"type":21},"2033-12-15",{"name":116,"class":56},"Assistance Publique - Hôpitaux de Paris"]