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Trial record 8 of 64 for:    Recruiting, Not yet recruiting, Available Studies | Drug allergy

Amoxicillin Challenge for Penicillin Allergy Diagnosis (Pen-VIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03757052
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : March 14, 2019
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Brief 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.

Condition or disease Intervention/treatment Phase
Penicillin Allergy Diagnostic Test: Penicillin Skin Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety, Validity and Efficiency of a Direct Graded Oral Challenge With Amoxicillin for the Evaluation of Penicillin Allergy in Adults
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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 Name: Amoxicillin Graded Oral Challenge

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Skin Tests Results [ Time Frame: 60 minutes ]
    Concordance of Skin Tests Results with Oral Challenge Results

  2. Severity of immediate hypersensitivity symptoms [ Time Frame: 60 minutes ]
    Mild, moderate and severe

  3. Delayed hypersensitivity symptoms [ Time Frame: 14 days ]
    Occurrence of delayed hypersensitivity symptoms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03757052

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Contact: Jean-Philippe Drolet, MD FRCPC 418-525-4444
Contact: Gaston De Serres, MD PhD 418-525-4444

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Canada, Quebec
CHU de Quebec Recruiting
Quebec city, Quebec, Canada
Contact: Jean-Philippe Drolet, MD         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
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Principal Investigator: Jean-Philippe Drolet, MD FRCPC CHU de Quebec-Universite Laval

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Responsible Party: CHU de Quebec-Universite Laval Identifier: NCT03757052     History of Changes
Other Study ID Numbers: 2019-4379
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Bacterial Agents
Anti-Infective Agents