NCT06406114 Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
| NCT ID | NCT06406114 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Drug Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2025-05-05 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Kimberly G Blumenthal, MD, MSc
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06406114 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Drug Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06406114 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06406114 currently recruiting?
Yes, NCT06406114 is actively recruiting participants. Contact the research team at cyelverton@mgh.harvard.edu for enrollment information.
Where is the NCT06406114 trial being conducted?
This trial is being conducted at Scottsdale, United States, San Francisco, United States, Boston, United States, Rochester, United States and 2 additional locations.
Who is sponsoring the NCT06406114 clinical trial?
NCT06406114 is sponsored by Massachusetts General Hospital. The principal investigator is Kimberly G Blumenthal, MD, MSc at Mayo Clinic. The trial plans to enroll 300 participants.