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NCT06406114 · ClinicalTrials.gov registry record · Phase 2
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
A Phase 2 study of Antibiotic Allergy and Drug Hypersensitivity, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 6
- Study locations
NCT06406114: Recruiting Phase 2 study of Antibiotic Allergy and Drug Hypersensitivity, sponsored by Massachusetts General Hospital.
NCT06406114 is a Phase 2 study of Antibiotic Allergy and Drug Hypersensitivity that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06406114, a Phase 2 study of Antibiotic Allergy and Drug Hypersensitivity, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Placebo-controlled drug challenges will be used to confirm or disprove participant's cephalosporin allergies, and the proportion of included participants with confirmed allergies will be measured.
Conditions Studied
Interventions
- DRUG Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing
- DRUG Culprit cephalosporin (cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime) double-blind placebo-controlled drug challenge
- DRUG Similar cephalosporin (cefepime, ceftriaxone, cefaclor, cephalexin, cefixime, or cefdinir) antibiotic double-blind placebo-controlled drug challenge
- DRUG Dissimilar cephalosporin (ceftriaxone or cefazolin) antibiotic double-blind placebo-controlled drug challenge
- DRUG Amoxicillin double-blind placebo-controlled drug challenge
Study Locations (6)
Arizona
- Mayo Clinic Arizona - Scottsdale
California
- University of California, San Francisco - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Rochester General Hospital - Rochester
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-05-05 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT06406114 shows while recruiting
NCT06406114 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 7 conditions, with Antibiotic Allergy appearing as the primary indexed condition, and to 5 interventions - of which Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing is the first listed.
NCT06406114 lists 6 locations in 6 states (Arizona, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06406114 about?
NCT06406114 is a clinical study titled "Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing". 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 ...
What is the current status of trial NCT06406114?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2025-05-05. Estimated completion is 2028-12-31.
What conditions does trial NCT06406114 study?
This clinical trial studies the following conditions: Antibiotic Allergy, Drug Hypersensitivity, Drug Allergy, Cephalosporin Allergy, Beta Lactam Adverse Reaction.
What interventions are being tested in trial NCT06406114?
The interventions under investigation include: Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing (DRUG), Culprit cephalosporin (cefazolin, ceftazidime, ceftriaxone, cefepime, cephalexin, cefaclor, cefadroxil, cefuroxime, cefpodoxime, cefdinir, or cefixime) double-blind placebo-controlled drug challenge (DRUG), Similar cephalosporin (cefepime, ceftriaxone, cefaclor, cephalexin, cefixime, or cefdinir) antibiotic double-blind placebo-controlled drug challenge (DRUG), Dissimilar cephalosporin (ceftriaxone or cefazolin) antibiotic double-blind placebo-controlled drug challenge (DRUG), Amoxicillin double-blind placebo-controlled drug challenge (DRUG).
Who is sponsoring clinical trial NCT06406114?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06406114 being conducted?
This trial has 6 study locations across Arizona, California, Massachusetts, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06406114's enrollment target sits among peer trials
300 167th of 2000 higher than 1,814 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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