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New treatment option for Drug Allergy
Official title Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
ClinicalTrials.gov ID: NCT06406114
What this study is testing
What is Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing?
Beta-lactam antibiotic (cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone, cefepime, pre-pen, penicillin G, ampicillin, and histamine) double-blind skin testing is an investigational medicine, being studied as a potential treatment for drug allergy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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 testing evidence.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years old.
- Reaction history consistent with a potential immediate hypersensitivity reaction (pruritus, urticaria, erythema, angioedema, bronchospasm, wheezing...
- English speaking or non-English speaking with translation services available.
You likely can't join if
- Severe concomitant medical condition (e.g., unstable coronary artery disease, congestive heart failure, severe chronic obstructive pulmonary 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
See the full eligibility 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...
- English speaking or non-English speaking with translation services available.
- 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...
- 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
- Significant immunosuppression
- Treatment with a beta-blocker or ACE inhibitor within 7 days
- Use of investigational drugs within 60 days of participation
- Anaphylaxis in the last 30 days
- Penicillin anaphylaxis within the past year confirmed with positive penicillin skin tests
- Prison or jail inmates, pregnant women, severe cognitive impairment
- Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- San Francisco, California, United States
- Boston, Massachusetts, United States
- Rochester, New York, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; San Francisco, California, United States; Boston, Massachusetts, United States; Rochester, New York, United States; Nashville, Tennessee, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.