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Compares treatment options for Penicillin Allergy
Official title Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
ClinicalTrials.gov ID: NCT06303128
What this study is testing
What is Amoxicillin 250 MG?
Amoxicillin 250 MG is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for penicillin allergy.
Also referred to as One-dose group.
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
- The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is: \- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?
- Phase 3: a large, late-stage study
- 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 89
You may be able to join if
- Expresses interest in participating by calling or filling out information form on study website
- Reports an allergy to one of the following medications: penicillin VK, penicillin G, amoxicillin, ampicillin, dicloxacillin, flucloxacillin...
You likely can't join if
- Penicillin allergy deemed to be more than "low-risk" per PEN-FAST (score ≥ 3 points)
- History of acute kidney injury (acute interstitial nephritis), severe liver impairment (drug- induced liver injury), serum sickness, or isolated drug...
- Anaphylaxis for any reason in the last year
- Cognitive impairment where a collateral history could not be obtained and/or patient does not have capacity to consent for themselves
- Pregnant (self-reported)
- Any illness or condition that would increase the risk of participation in the study, per the evaluating clinician's judgment
See the full eligibility criteria
- Expresses interest in participating by calling or filling out information form on study website
- Reports an allergy to one of the following medications: penicillin VK, penicillin G, amoxicillin, ampicillin, dicloxacillin, flucloxacillin, nafcillin, oxacillin, amoxicillin- clavulanate, ampicillin-sulbactam. people...
- Penicillin allergy deemed to be more than "low-risk" per PEN-FAST (score ≥ 3 points)
- History of acute kidney injury (acute interstitial nephritis), severe liver impairment (drug- induced liver injury), serum sickness, or isolated drug fever attributed to a penicillin- based antibiotic
- Anaphylaxis for any reason in the last year
- Cognitive impairment where a collateral history could not be obtained and/or patient does not have capacity to consent for themselves
- Pregnant (self-reported)
- Any illness or condition that would increase the risk of participation in the study, per the evaluating clinician's judgment
- Active treatment of or history of acute angle closure glaucoma
- On H1- or H2-blockers (i.e. diphenhydramine, hydroxyzine, chlorpheniramine, cetirizine, levocetirizine, loratadine, fexofenadine or famotidine, ranitidine, cimetidine, nizatidine, respectively) within 72 hours of...
- Actively receiving greater than stress dose steroid (hydrocortisone \>50mg four times a day or steroid equivalent)
- Actively receiving any antibiotic
- Relative contraindication: Patients on beta blockers and angiotensin converting enzyme inhibitors (ACE inhibitors) will have an open dialog with the study team regarding the risks and benefits of testing a low-risk...
The study team makes the final eligibility decision.
Where it's taking place
- Lubbock, 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 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lubbock, 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.