Optimizing allergy testing for cephalosporin antibiotics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to improve the diagnostic approach for patients with suspected cephalosporin allergies, which can lead to severe allergic reactions. The study will involve double-blind skin testing and drug challenges with various beta-lactam antibiotics to better understand the mechanisms of cephalosporin allergy. By identifying the antigenic determinants and validating skin testing, the trial seeks to enhance future diagnostic methods for patients with drug hypersensitivity. The research will also explore the cross-reactivity of cephalosporins with other beta-lactam antibiotics.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

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

Where it's running

• Mayo Clinic Arizona
  Scottsdale, Arizona, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Rochester General Hospital
  Rochester, New York, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Kimberly G Blumenthal, MD, MSc — Mayo Clinic
• Study coordinator: Cara Yelverton, BSc, PhD
• Email: cyelverton@mgh.harvard.edu
• Phone: 6177242415

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.