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Amoxicillin Challenge for Penicillin Allergy Diagnosis (Pen-VIE Trial)

N/A
Waitlist Available
Led By Jean-Philippe Drolet, MD FRCPC
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
No Placebo-Only Group

Summary

False diagnosis of penicillin allergy are frequently reported, and have been proven detrimental to patients. Current guidelines for the assessment of drug allergies recommend that penicillin allergy be evaluated first with prick and intradermal skin tests, and then completed with a graded oral challenge, spread over at least two doses. However, it has been shown that these skin tests, in addition to consuming resources and time, are of limited, or even doubtful validity, given the poor predictive values that have been reported in the modern penicillins era. It now seems unreasonable to continue their use without addressing other, more efficient diagnostic stategies. Several groups have now demonstrated the safety, validity, and efficiency of a direct, two-step amoxicillin oral challenge (starting with 10% of the standard therapeutic dose, followed by 90 % of the dose), without prior skin tests, first for any type of reaction in the pediatric population, then for any non-immediate reaction in the adult population. The objective of this study is to demonstrate the safety, efficiency, and validity of direct, two-step graded oral challenge with amoxicillin for the evaluation of any reported penicillin allergy in the adult population, excluding high-risk patients (documented anaphylaxis to a penicillin in the last 5 years). Skin tests will first be performed according to the protocol currently in use at the CHUL, then consented patients will proceed with the graded oral challenge still according to the protocol currently in use at the CHUL, but regardless of the skin tests results. The results of the two tests will be compared to determine the safety, efficiency and validity of proceeding directly to the graded oral challenge.

Eligible Conditions
  • Penicillin Allergy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Type 1 Hypersensitivity Reaction
Secondary study objectives
Delayed hypersensitivity symptoms
Severity of immediate hypersensitivity symptoms
Skin Tests Results

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Skin testing and Graded Oral ChallengeExperimental Treatment1 Intervention
Penicillin skin testing as described in the intervention section, followed by amoxicillin graded oral challenge as described in the intervention section

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
172 Previous Clinical Trials
108,675 Total Patients Enrolled
Jean-Philippe Drolet, MD FRCPCPrincipal InvestigatorCHU de Quebec-Universite Laval
~143 spots leftby Dec 2025