Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Age 18-70 years old.
• 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.
• English speaking or non-English speaking with translation services available.
Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Scottsdale
California
University of California, San Francisco
NOT_YET_RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
New York
Rochester General Hospital
RECRUITING
Rochester
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Cara Yelverton, BSc, PhD
cyelverton@mgh.harvard.edu
6173120387
Backup
Kell Lopez, BS
klopez5@bwh.harvard.edu
6177320589
Time Frame
Start Date:2025-05-05
Estimated Completion Date:2028-12-31
Participants
Target number of participants:300
Treatments
Experimental: Similar cephalosporin first
In visit 2, confirmed-allergic subjects will have a double-blind placebo-controlled drug challenge to a similar side chain cephalosporin, followed by a double-blind placebo-controlled challenge to a dissimilar side chain cephalosporin in visit 3. The randomization of which cephalosporin (similar or dissimilar side chain) is challenged in visits 2 and 3 differentiates the two arms.
Experimental: Dissimilar cephalosporin first
In visit 2, confirmed-allergic subjects will have a double-blind placebo-controlled drug challenge to a dissimilar side chain cephalosporin, followed by a double-blind placebo-controlled challenge to a similar side chain cephalosporin in visit 3. The randomization of which cephalosporin (similar or dissimilar side chain) is challenged in visits 2 and 3 differentiates the two arms.