Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on improving the way doctors diagnose allergies to cephalosporin antibiotics, which are often used to treat infections. Some people can have serious allergic reactions, known as hypersensitivity, to these medications. Currently, there isn’t a clear method for testing and confirming these allergies, which can lead to confusion when doctors try to find safe alternatives for patients who are allergic. The study aims to find better ways to test for cephalosporin allergies and improve future diagnostic methods.

To be eligible for this study, participants should be between 18 and 70 years old and have a history of allergic reactions to specific cephalosporin antibiotics, such as cefazolin or cephalexin. However, those with certain severe health conditions or recent serious allergic events won't be able to take part. If someone joins the study, they can expect to undergo various tests and evaluations to help researchers understand cephalosporin allergies better. The trial is currently not recruiting participants, but it represents an important step in making antibiotic use safer for people with allergies.

Gender

ALL

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