Amoxicillin Challenge for Penicillin Allergy Diagnosis (Pen-VIE)

March 13, 2019 updated by: CHU de Quebec-Universite Laval

Safety, Validity and Efficiency of a Direct Graded Oral Challenge With Amoxicillin for the Evaluation of Penicillin Allergy in Adults

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Quebec city, Quebec, Canada
        • Recruiting
        • CHU de Québec
        • Contact:
          • Jean-Philippe Drolet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being 18 years of age or older at the time of the test
  • Being referred by a health professional for the evaluation of any allergic reaction to a penicillin, including natural penicillins, anti-staphylococcal penicillins, aminopenicillins, penicillins combined with a beta-lactamase inhibitor, and carboxypenicillins ; or an antibiotic of the beta-lactam family, whose assessment requires testing for penicillins, according to the treating allergist

Exclusion Criteria:

  • Pregnancy
  • Poorly controlled asthma, chronic lung disease or heart disease
  • Failure to stop beta-blockers prior to the test
  • Occurrence of the reaction in the 4 weeks preceding the test (possibility of false negatives)
  • History of severe delayed hypersensitivity reaction, reaction requiring hospitalization of more than 24 hours, or bullous, pustular, exfoliative or mucosal reaction (excluding angioedema)
  • Recent anaphylaxis (<5 years), defined as concomitant involvement of at least two systems (respiratory, digestive, mucocutaneous or cardiovascular) within one hour of administration of the drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin testing and Graded Oral Challenge
Penicillin skin testing as described in the intervention section, followed by amoxicillin graded oral challenge as described in the intervention section
Diagnostic test: Penicillin Skin Testing
Skin test protocol: prick skin tests (penicilloyl-polylysine 0.000012 mol/0.05 mL, penicillin G 10,000 U/mL, penoate 10,000 U/mL, ampicillin 100 mg/mL, amoxicillin 71 mg/mL, histamine/positive control, diluent/negative control), then intradermal skin tests (penicilloyl-polylysine 0.000012 mol/0.05 mL, penicillin G 10,000 U/mL, penoate 10,000 U/mL, ampicillin 1 mg/mL, diluent/negative control), administered as an intradermal injection of a standardized volume of 0.02 mL. Graded oral challenge with amoxicillin : a first dose of 50 mg of amoxicillin; 20-minute observation period; in the absence of any objective symptom of an allergic reaction, a second dose of amoxicillin of 450 mg; final observation period of 60 minutes, under nurse and medical supervision.
Other Names:
  • Amoxicillin Graded Oral Challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 1 Hypersensitivity Reaction
Time Frame: 60 minutes
The primary outcome is the occurrence of immediate hypersensitivity symptoms, occuring during the test period, which is up to 60 minutes after the last dose of amoxicillin.
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Tests Results
Time Frame: 60 minutes
Concordance of Skin Tests Results with Oral Challenge Results
60 minutes
Severity of immediate hypersensitivity symptoms
Time Frame: 60 minutes
Mild, moderate and severe
60 minutes
Delayed hypersensitivity symptoms
Time Frame: 14 days
Occurrence of delayed hypersensitivity symptoms
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Investigators

  • Principal Investigator: Jean-Philippe Drolet, MD FRCPC, CHU de Quebec-Universite Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-4379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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