RecruitingPhase 2

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

United States300 participantsStarted 2025-05-05

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.)
✕. History of Clostridioides difficile infection
✕. Chronic spontaneous urticaria or systemic mastocytosis
✕. Incident reaction required cardiopulmonary resuscitation
✕. Reaction to 2 or more cephalosporin antibiotics
✕. Active infection or antibiotic treatment within 7 days
✕. Treatment with systemic antihistamines or corticosteroids within 7 days
✕. Treatment with omalizumab or dupilumab within 60 days

What they're measuring

Proportion of participants with confirmed culprit cephalosporin allergy

Timeframe: Up to 7 weeks

Cephalosporin skin test sensitivity and specificity

Timeframe: Up to 7 weeks

Proportion of cross-reactivity to other cephalosporins in confirmed-allergic subjects

Timeframe: Up to 7 weeks

Trial details

NCT IDNCT06406114

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Cara Yelverton, BSc, PhD

6173120387 cyelverton@mgh.harvard.edu

View on ClinicalTrials.gov More Drug Allergy trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.)
✕. History of Clostridioides difficile infection
✕. Chronic spontaneous urticaria or systemic mastocytosis
✕. Incident reaction required cardiopulmonary resuscitation
✕. Reaction to 2 or more cephalosporin antibiotics
✕. Active infection or antibiotic treatment within 7 days
✕. Treatment with systemic antihistamines or corticosteroids within 7 days
✕. Treatment with omalizumab or dupilumab within 60 days