Actively Recruiting
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
Led by Massachusetts General Hospital · Updated on 2026-03-19
300
Participants Needed
6
Research Sites
190 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old
- History of immediate allergic reaction symptoms to specified cephalosporin antibiotics
- English speaking or with available translation services
You will not qualify if you...
- Severe medical conditions such as unstable coronary artery disease, congestive heart failure, severe COPD, poorly controlled asthma, chronic renal failure, cirrhosis, or end-stage liver disease
- History of Clostridioides difficile infection
- Chronic spontaneous urticaria or systemic mastocytosis
- Prior reaction requiring cardiopulmonary resuscitation
- Allergy to two or more cephalosporin antibiotics
- Active infection or antibiotic use within 7 days
- Use of systemic antihistamines or corticosteroids within 7 days
- Treatment with omalizumab or dupilumab within 60 days
- Significant immunosuppression
- Use of beta-blockers or ACE inhibitors within 7 days
- Participation in investigational drug studies within 60 days
- Anaphylaxis in the last 30 days
- Penicillin anaphylaxis within the past year confirmed by skin testing
- Prison or jail inmates, pregnant women, or severe cognitive impairment
- Current diagnosed mental illness or drug/alcohol abuse interfering with participation
- Other medical problems or laboratory findings posing risks or interfering with study compliance
- Inability or unwillingness to give informed consent or comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 14607
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Rochester General Hospital
Rochester, New York, United States, 14621
Actively Recruiting
5
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
C
Cara Yelverton, BSc, PhD
CONTACT
K
Kell Lopez, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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