Optimizing allergy testing for cephalosporin antibiotics

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

This study is testing a new way to diagnose cephalosporin allergies in patients to help them avoid severe allergic reactions.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Drugs / interventions: omalizumab, dupilumab
• Locations: 6 sites (Scottsdale, Arizona and 5 other locations)
• Trial ID: NCT06406114 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 who have a history of immediate hypersensitivity reactions to specific cephalosporin antibiotics.

Not a fit: Patients with severe concomitant medical conditions or those who have reacted to multiple cephalosporin antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses of cephalosporin allergies, allowing patients to receive safer antibiotic treatments.

How similar studies have performed: While there is limited validation for cephalosporin allergy testing, previous studies on penicillin allergy testing have shown success, indicating potential for this novel approach.

Eligibility criteria

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 this trial is running

Scottsdale, Arizona and 5 other locations

• 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

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