[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547295":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":45,"centralContacts":53,"locations":63,"responsibleParty":186,"collaborators":189,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":195,"sex":200,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":28,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":218,"overallStatus":66,"whyStopped":28,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Similar cephalosporin first","EXPERIMENTAL","In visit 2, confirmed-allergic subjects will have a double-blind placebo-controlled drug challenge to a similar side chain cephalosporin, followed by a double-blind placebo-controlled challenge to a dissimilar side chain cephalosporin in visit 3. The randomization of which cephalosporin (similar or dissimilar side chain) is challenged in visits 2 and 3 differentiates the two arms.",[13,14,15,16,17],"Drug: Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing","Drug: Culprit cephalosporin (cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime) double-blind placebo-controlled drug challenge","Drug: Similar cephalosporin (cefepime, ceftriaxone, cefaclor, cephalexin, cefixime, or cefdinir) antibiotic double-blind placebo-controlled drug challenge","Drug: Dissimilar cephalosporin (ceftriaxone or cefazolin) antibiotic double-blind placebo-controlled drug challenge","Drug: Amoxicillin double-blind placebo-controlled drug challenge",{"label":19,"type":10,"description":20,"interventionNames":21},"Dissimilar cephalosporin first","In visit 2, confirmed-allergic subjects will have a double-blind placebo-controlled drug challenge to a dissimilar side chain cephalosporin, followed by a double-blind placebo-controlled challenge to a similar side chain cephalosporin in visit 3. The randomization of which cephalosporin (similar or dissimilar side chain) is challenged in visits 2 and 3 differentiates the two arms.",[13,14,15,16,17],[23,29,33,37,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing","Percutaneous and intradermal skin testing will be performed in all participants. Concentrations for percutaneous testing; cefazolin (330 mg\u002Fml), cefuroxime (90 mg\u002Fml), ceftazidime (100 mg\u002Fml), ceftriaxone (100 mg\u002Fml), cefepime (200 mg\u002Fml), pre-pen (undiluted), penicillin G (10,000 U\u002Fml), ampicillin (20 mg\u002Fml) and histamine (6 mg\u002Fml). Concentrations for the first intradermal testing; cefazolin (3.3mg\u002Fml), cefuroxime (1 mg\u002Fml), ceftazidime (1 mg\u002Fml), ceftriaxone (1 mg\u002Fml), cefepime (2 mg\u002Fml), Pre-PEN (undiluted), penicillin G (1000 U\u002Fml), ampicillin (20 mg\u002Fml), and histamine (0.1 mg\u002Fml). Concentrations for the second intradermal testing; cefazolin (33mg\u002Fml), cefuroxime (10 mg\u002Fml), ceftazidime (10 mg\u002Fml), ceftriaxone (10 mg\u002Fml), cefepime (20 mg\u002Fml), Pre-PEN (undiluted), penicillin G (10,000 U\u002Fml), ampicillin (20 mg\u002Fml) and histamine (0.1 mg\u002Fml). Histamine and saline will be used as positive and negative controls.",[19,9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Culprit cephalosporin (cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime) double-blind placebo-controlled drug challenge","After double-blind skin testing, participants will undergo a 3-step double-blind placebo-controlled drug challenge to their culprit cephalosporin (the cephalosporin they are suspected to be allergic to, either cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime). The challenges are 1:1 randomized to the order of active drug versus placebo. In Step 1, participants will receive 1:1000 of a full dose of either the culprit drug or placebo, followed by a 30-minute observation period. In Step 2, participants will receive 1:50 of a full dose of either, followed by another 30-minute observation period. In Step 3, participants are administered the full dose of either agent, followed by a 60-minute observation period. The same testing process is repeated for the second challenge.",[19,9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Similar cephalosporin (cefepime, ceftriaxone, cefaclor, cephalexin, cefixime, or cefdinir) antibiotic double-blind placebo-controlled drug challenge","Participants will undergo a 3-step double-blind placebo-controlled drug challenge to a cephalosporin antibiotic that shares a similar side chain with their culprit. This will be cefepime for those allergic to ceftriaxone, cefaclor for those allergic to cephalexin, cefixime for those allergic to cefdinir, cefdinir for those allergic to cefixime, cephalexin for those allergic to cefaclor or cephadroxil, and ceftriaxone for those allergic to cefepime, cefuroxime, or cefpodoxime. The challenges are 1:1 randomized to the order of active drug versus placebo. In Step 1, participants will receive 1:1000 of a full dose of either the culprit drug or placebo, followed by a 30-minute observation period. In Step 2, participants will receive 1:50 of a full dose of either, followed by another 30-minute observation period. In Step 3, participants are administered the full dose of either agent, followed by a 60-minute observation period. The same testing process is repeated for the second challenge.",[19,9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Dissimilar cephalosporin (ceftriaxone or cefazolin) antibiotic double-blind placebo-controlled drug challenge","Participants will undergo a 3-step double-blind placebo-controlled drug challenge to a cephalosporin antibiotic that has a dissimilar side chain to their culprit. This will be ceftriaxone for those allergic to cefazolin, and cefazolin for those allergic to any other cephalosporin. The challenges are 1:1 randomized to the order of active drug versus placebo. In Step 1, participants will receive 1:1000 of a full dose of either the culprit drug or placebo, followed by a 30-minute observation period. In Step 2, participants will receive 1:50 of a full dose of either, followed by another 30-minute observation period. In Step 3, participants are administered the full dose of either agent, followed by a 60-minute observation period. The same testing process is repeated for the second challenge.",[19,9],{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"Amoxicillin double-blind placebo-controlled drug challenge","Participants will optionally undergo a 3-step double-blind placebo-controlled drug challenge to Amoxicillin. The challenges are 1:1 randomized to the order of active drug versus placebo. In Step 1, participants will receive 1:1000 of a full dose of either the culprit drug or placebo, followed by a 30-minute observation period. In Step 2, participants will receive 1:50 of a full dose of either, followed by another 30-minute observation period. In Step 3, participants are administered the full dose of either agent, followed by a 60-minute observation period. The same testing process is repeated for the second challenge. The order of challenge to similar vs. dissimilar cephalosporin will be randomized as well.",[19,9],[46,50],{"name":47,"affiliation":48,"role":49},"Kimberly G Blumenthal, MD, MSc","Mayo Clinic","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":52,"role":49},"David A Khan, MD","University of Texas Southwestern Medical Center",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":28,"email":58},"Cara Yelverton, BSc, PhD","CONTACT","6173120387","cyelverton@mgh.harvard.edu",{"name":60,"role":56,"phone":61,"phoneExt":28,"email":62},"Kell Lopez, BS","6177320589","klopez5@bwh.harvard.edu",[64,88,107,126,147,167],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Mayo Clinic Arizona","RECRUITING","Scottsdale","Arizona","14607","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-111.89903,33.50921,{"lat":76,"lon":75},[79,83,87],{"name":80,"role":56,"phone":81,"phoneExt":28,"email":82},"Alexei Gonzalez-Estrada, MD","904-953-2451","gonzalez.alexei@mayo.edu",{"name":84,"role":56,"phone":85,"phoneExt":28,"email":86},"Renee Nunez, BS","480-574-1826","Nunez.Renee@mayo.edu",{"name":80,"role":49,"phone":28,"phoneExt":28,"email":28},{"facility":89,"status":66,"city":90,"state":91,"zip":92,"country":70,"countryCode":71,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"University of California, San Francisco","San Francisco","California","94143",{"type":73,"coordinates":94},[95,96],-122.41942,37.77493,{"lat":96,"lon":95},[99,103],{"name":100,"role":56,"phone":101,"phoneExt":28,"email":102},"Monica Tang, MD","415-514-8044","dacat@ucsf.edu",{"name":104,"role":56,"phone":105,"phoneExt":28,"email":106},"Lina Kamil","916-743-8466","Lina.Kamil@ucsf.edu",{"facility":5,"status":66,"city":108,"state":109,"zip":110,"country":70,"countryCode":71,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Boston","Massachusetts","02114",{"type":73,"coordinates":112},[113,114],-71.05977,42.35843,{"lat":114,"lon":113},[117,121,125],{"name":118,"role":56,"phone":119,"phoneExt":28,"email":120},"Aleena Banerji, MD","6177263850","ABANERJI@mgh.harvard.edu",{"name":122,"role":56,"phone":123,"phoneExt":28,"email":124},"Dylan Norton, BS","617-726-2974","dtnorton@mgh.harvard.edu",{"name":118,"role":49,"phone":28,"phoneExt":28,"email":28},{"facility":127,"status":66,"city":128,"state":129,"zip":130,"country":70,"countryCode":71,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Rochester General Hospital","Rochester","New York","14621",{"type":73,"coordinates":132},[133,134],-77.61556,43.15478,{"lat":134,"lon":133},[137,141,145],{"name":138,"role":56,"phone":139,"phoneExt":28,"email":140},"Allison C Ramsey, MD","585-922-8350","allison.ramsey@rochesterregional.org",{"name":142,"role":56,"phone":143,"phoneExt":28,"email":144},"Dawn Shefflin, RN","585-922-8314","dawn.sheflin@rochesterregional.org",{"name":146,"role":49,"phone":28,"phoneExt":28,"email":28},"Allison C Ramsay, MD",{"facility":148,"status":66,"city":149,"state":150,"zip":151,"country":70,"countryCode":71,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":73,"coordinates":153},[154,155],-86.78444,36.16589,{"lat":155,"lon":154},[158,162,166],{"name":159,"role":56,"phone":160,"phoneExt":28,"email":161},"Elizabeth Phillips, MD","6153100339","elizabeth.j.phillips@vumc.org",{"name":163,"role":56,"phone":164,"phoneExt":28,"email":165},"April O'Conner, RN","615-957-6057","april.oconnor@vumc.org",{"name":159,"role":49,"phone":28,"phoneExt":28,"email":28},{"facility":52,"status":66,"city":168,"state":169,"zip":170,"country":70,"countryCode":71,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Dallas","Texas","75390",{"type":73,"coordinates":172},[173,174],-96.80667,32.78306,{"lat":174,"lon":173},[177,180,184],{"name":51,"role":56,"phone":178,"phoneExt":28,"email":179},"214-406-5119","Dave.Khan@UTSouthwestern.edu",{"name":181,"role":56,"phone":182,"phoneExt":28,"email":183},"Deborah Gonzales, BS","214-648-7602","deborah.gonzales@utsouthwestern.edu",{"name":185,"role":49,"phone":28,"phoneExt":28,"email":28},"Dave Khan, MD",{"type":49,"investigatorFullName":187,"investigatorTitle":188,"investigatorAffiliation":48,"oldNameTitle":28,"oldOrganization":28},"Kimberly Blumenthal, MD, MSc","Principal Investigator",[190],{"name":191,"class":192},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","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":204,"type":205},300,"ESTIMATED","INTERVENTIONAL",[208],"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.",[211,212,213,214,215,216,217],"Drug Allergy","Cephalosporin Allergy","Drug Hypersensitivity","Antibiotic Allergy","Beta Lactam Adverse Reaction","Drug-Induced Anaphylaxis","Cephalosporin Reaction",[219,220,221,222,223,224,225,226,227,228],"Allergy","Antibiotic","Cephalosporin","Penicillin","Beta-lactam","Drug challenge","Skin testing","Adverse reaction","Anaphylaxis","Perioperative anaphylaxis","2026-05-22",{"date":231,"type":232},"2026-05-26","ACTUAL",{"date":234,"type":232},"2025-05-05",{"date":236,"type":205},"2028-12-31",{"name":5,"class":6},6]