[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"beta-lactam-adverse-reaction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:beta-lactam-adverse-reaction":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"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":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100619286","optimization-of-perioperative-antibiotic-prophylaxis-in-patients-allergic-to-beta-lactams-in-the-orthopedic-surgery-and-trauma-departments-100619286","NCT07342647","Optimization of Perioperative Antibiotic Prophylaxis in Patients Allergic to Beta-lactams in the Orthopedic Surgery and Trauma Departments","Optimization of Perioperative Antibiotic Prophylaxis in Patients Allergic to Beta-lactams in the Orthopedic Surgery and Trauma Departments of the Strasbourg University Hospitals","ORTHO-PEN","Inclusion Criteria:\n\n* Adult patient (≥ 18 years old)\n* Patient operated on at Strasbourg University Hospital between January 1, 2023, and December 31, 2023, for total knee, shoulder, or hip replacement.\n* Patients who underwent surgery at Strasbourg University Hospital between March 1, 2025, and July 31, 2025, involving surgery requiring intraoperative antibiotic prophylaxis.\n\nExclusion Criteria:\n\n* Patients with a surgical indication without the use of implants.\n* Patients with a surgical indication without antibiotic prophylaxis.",{"count":67,"type":21},50,"OBSERVATIONAL","When surgery is required, a consultation with an anesthesiologist is mandatory. This preoperative consultation allows for the selection of the appropriate antibiotic prophylaxis tailored to the patient and the type of procedure. The French Society of Anesthesiology and Intensive Care (SFAR) has published recommendations on antibiotic prophylaxis for different types of surgery. During this consultation, several topics are addressed, including drug allergies. This topic plays a central role in the choice of antibiotic prophylaxis.\n\nTen percent of the population is labeled as allergic to beta-lactams, but only 1% actually are. Diagnosis is difficult and requires specialized teams. In response to the significant increase in patients labeled as allergic, and consequently the rise in requests to specialists, a scoring system has been developed for use by all physicians: the PEN FAST score. This score stratifies the risk of a true penicillin allergy and guides the selection of delabeling strategies. The test aims to eliminate the need for skin prick tests and allows for the direct reintroduction of the drug when the score is below 3. It is based on five questions. Each question is assigned a point value, which is used to calculate a score and thus an estimated risk.\n\nThe primary objective of this study is to improve the management of patients allergic to beta-lactams in orthopedic and trauma surgery by ensuring optimal and appropriate intraoperative antibiotic prophylaxis.",[31],[31,72,73,74],"Antibiotic Prophylaxis","Beta-Lactamines","Orthopedic Surgery","2026-01-06",{"date":77,"type":49},"2026-01-15",{"date":79,"type":49},"2025-07-11",{"date":81,"type":21},"2026-07-11",{"name":83,"class":56},"University Hospital, Strasbourg, France",1]