Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

Description

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.

Conditions

Drug Allergy, Cephalosporin Allergy, Drug Hypersensitivity, Antibiotic Allergy, Beta Lactam Adverse Reaction, Drug-Induced Anaphylaxis, Cephalosporin Reaction

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Study Overview

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Study Details

Study overview

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.

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

Condition
Drug Allergy
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic Arizona, Scottsdale, Arizona, United States, 14607

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Rochester

Rochester General Hospital, Rochester, New York, United States, 14621

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 18-70 years old.
  • 2. 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.
  • 3. English speaking or non-English speaking with translation services available.
  • 1. 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.)
  • 2. History of Clostridioides difficile infection
  • 3. Chronic spontaneous urticaria or systemic mastocytosis
  • 4. Incident reaction required cardiopulmonary resuscitation
  • 5. Reaction to 2 or more cephalosporin antibiotics
  • 6. Active infection or antibiotic treatment within 7 days
  • 7. Treatment with systemic antihistamines or corticosteroids within 7 days
  • 8. Treatment with omalizumab or dupilumab within 60 days
  • 9. Significant immunosuppression
  • 10. Treatment with a beta-blocker or ACE inhibitor within 7 days
  • 11. Use of investigational drugs within 60 days of participation
  • 12. Anaphylaxis in the last 30 days
  • 13. Penicillin anaphylaxis within the past year confirmed with positive penicillin skin tests
  • 14. Prison or jail inmates, pregnant women, severe cognitive impairment
  • 15. 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
  • 16. 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.
  • 17. Inability or unwillingness of a participant to give written informed consent or comply with study protocol

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Kimberly G Blumenthal, MD, MSc, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

David A Khan, MD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

2028-12-31