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
NOT_YET_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.