Allergy Asthma Proc. 2019 Jan 1;40(1):57-61. doi: 10.2500/aap.2019.40.4184.
Direct oral amoxicillin challenge without preliminary skin testing in adult patients with allergy and at low risk with reported penicillin allergy.
Kuruvilla M1, Shih J1, Patel K1, Scanlon N2.
Author information
1
From the Department of Allergy/Immunology, Emory University, Atlanta, Georgia.
2
Department of Internal Medicine, Emory University, Atlanta, Georgia.
Abstract
Introduction: Ten percent of hospitalized patients report penicillin allergy; however, recent studies indicate that ∼98% of these patients are not acutely hypersensitive. Unconfirmed penicillin allergy poses public health risks, and an evaluation of penicillin allergy labels is recommended to improve antibiotic stewardship. Although the most widely accepted protocol is penicillin skin testing, followed by oral amoxicillin challenge, time constraints and resources may preclude this. Recent literature supports the safety and efficacy of direct oral amoxicillin challenge in individuals at low risk. Methods: We retrospectively evaluated direct oral challenge acceptance and outcomes in eligible adult outpatients with allergy and with a penicillin allergy label over a 6-month period. Direct oral amoxicillin challenge was recommended in patients with a history of benign rash, benign somatic symptoms, or unknown history associated with the last penicillin exposure >12 months ago. Those with severe reactions or reactions within 12 months of evaluation were not challenged. The patients were monitored for 60 minutes after challenge and were discharged with instructions to call in the event of a delayed reaction. Results: There were 50 of 355 adults (14%) with a penicillin allergy label seen by a single allergist; of these patients, 38 (76%) met our criteria for a direct oral challenge. The index penicillin associated reactions were mostly remote, and 44 subjects (88%) reported reactions >10 years earlier. Four patients (8%) were de-labeled based on history alone. Twenty subjects (40%) consented to challenge in the clinic, and none developed immediate, or to our knowledge, delayed hypersensitivity reactions. Three of 20 patients (15%) developed self-limited subjective symptoms that were not deemed to constitute true immunoglobulin E mediated hypersensitivity. A total of 24 patients (48%) had the penicillin allergy label removed from their medical record. Conclusion: This study added to the accumulating body of evidence that supports the safety and efficacy of direct provocative challenge without preliminary skin testing to exclude penicillin allergy in individuals at low risk. Larger prospective studies are necessary to confirm these observations.
PMID: 30582497 DOI: 10.2500/aap.2019.40.4184
Direct oral amoxicillin challenge without preliminary skin testing in adult patients with allergy and at low risk with reported penicillin allergy.
Kuruvilla M1, Shih J1, Patel K1, Scanlon N2.
Author information
1
From the Department of Allergy/Immunology, Emory University, Atlanta, Georgia.
2
Department of Internal Medicine, Emory University, Atlanta, Georgia.
Abstract
Introduction: Ten percent of hospitalized patients report penicillin allergy; however, recent studies indicate that ∼98% of these patients are not acutely hypersensitive. Unconfirmed penicillin allergy poses public health risks, and an evaluation of penicillin allergy labels is recommended to improve antibiotic stewardship. Although the most widely accepted protocol is penicillin skin testing, followed by oral amoxicillin challenge, time constraints and resources may preclude this. Recent literature supports the safety and efficacy of direct oral amoxicillin challenge in individuals at low risk. Methods: We retrospectively evaluated direct oral challenge acceptance and outcomes in eligible adult outpatients with allergy and with a penicillin allergy label over a 6-month period. Direct oral amoxicillin challenge was recommended in patients with a history of benign rash, benign somatic symptoms, or unknown history associated with the last penicillin exposure >12 months ago. Those with severe reactions or reactions within 12 months of evaluation were not challenged. The patients were monitored for 60 minutes after challenge and were discharged with instructions to call in the event of a delayed reaction. Results: There were 50 of 355 adults (14%) with a penicillin allergy label seen by a single allergist; of these patients, 38 (76%) met our criteria for a direct oral challenge. The index penicillin associated reactions were mostly remote, and 44 subjects (88%) reported reactions >10 years earlier. Four patients (8%) were de-labeled based on history alone. Twenty subjects (40%) consented to challenge in the clinic, and none developed immediate, or to our knowledge, delayed hypersensitivity reactions. Three of 20 patients (15%) developed self-limited subjective symptoms that were not deemed to constitute true immunoglobulin E mediated hypersensitivity. A total of 24 patients (48%) had the penicillin allergy label removed from their medical record. Conclusion: This study added to the accumulating body of evidence that supports the safety and efficacy of direct provocative challenge without preliminary skin testing to exclude penicillin allergy in individuals at low risk. Larger prospective studies are necessary to confirm these observations.
PMID: 30582497 DOI: 10.2500/aap.2019.40.4184
Evaluating Penicillin Allergies Without Skin Testing AbstractPurpose of ReviewAn unconfirmed penicillin allergy is known to confer significant risk to patients. Only a small minority of patients labeled with penicillin allergy will be confirmed to be hypersensitive with the current reference standard test, an oral amoxicillin therapeutic dose challenge. Skin testing has been recommended prior to oral challenges to reduce the risk of severe acute challenge reactions. The rate of severe acute anaphylactic reactions with oral amoxicillin is currently extremely low. Unfortunately, penicillin skin testing, as commonly performed, has a high rate of false positive results. Recent FindingsEncouraging skin testing in all individuals with an unconfirmed penicillin allergy, prior to a confirmatory oral challenge, would be technically difficult, make testing all individuals with an unconfirmed penicillin allergy very unlikely, and ultimately increase the risk to patients because of suboptimal antibiotic use. Most patients, who are appropriate candidates for a direct oral amoxicillin challenge, to confirm current penicillin tolerance, can be safely identified by their clinical histories. Higher risk individuals, those with a history of anaphylaxis or other acute onset potentially IgE-mediated reaction such as hives within 6 h of the first dose of the last course of a penicillin, may benefit from properly performed puncture and intradermal skin testing, using commercially available penicilloyl-polylysine, prior to an oral challenge, if skin test negative. SummaryDirect oral amoxicillin challenges in low-risk individuals are well accepted by patients and a safe and effective part of penicillin allergy delabeling. |
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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.
ClinicalTrials.gov Identifier: NCT03757052
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : March 14, 2019
See Contacts and Locations
Sponsor:
CHU de Quebec-Universite Laval
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval
Study Details Tabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
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
Study Design
Go to sections
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
Drug Information available for: Penicillins Amoxicillin Amoxicillin sodium
U.S. FDA Resources
Arms and Interventions
Go to sections
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
Outcome Measures
Go to sections
Primary Outcome Measures :
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 :
Skin Tests Results [ Time Frame: 60 minutes ]
Concordance of Skin Tests Results with Oral Challenge Results
Severity of immediate hypersensitivity symptoms [ Time Frame: 60 minutes ]
Mild, moderate and severe
Delayed hypersensitivity symptoms [ Time Frame: 14 days ]
Occurrence of delayed hypersensitivity symptoms
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
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
Contacts and Locations
Go to sections
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 ClinicalTrials.gov identifier (NCT number): NCT03757052
Contacts
Contact: Jean-Philippe Drolet, MD FRCPC 418-525-4444 jean-philippe.drolet@chudequebec.ca
Contact: Gaston De Serres, MD PhD 418-525-4444 Gaston.DeSerres@inspq.qc.ca
Locations
Canada, Quebec
CHU de Quebec Recruiting
Quebec city, Quebec, Canada
Contact: Jean-Philippe Drolet, MD
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Principal Investigator: Jean-Philippe Drolet, MD FRCPC CHU de Quebec-Universite Laval
More Information
Go to sections
Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov 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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Amoxicillin
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents
TO TOP
For Patients and Families For Researchers For Study Record Managers
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U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms
x
Accepts healthy volunteers
Active comparator arm
Adverse event
Age or age group
All-cause mortality
Allocation
Arm
Arm type
Baseline characteristics
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Certification
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Certification/extension first submitted that met QC criteria
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Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
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Phase 4
Phase Not Applicable
Placebo
Placebo comparator arm
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Primary outcome measure
Primary purpose
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Protocol
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Registration
Removed location countries
Reporting group
Responsible party
Results database
Results delayed
Results first posted
Results first submitted
Results first submitted that met QC criteria
Results returned after quality control review
Results submitted to ClinicalTrials.gov
Secondary outcome measure
Serious adverse event
Sex
Sham comparator arm
Single group assignment
Sort studies by
Sponsor
State
Statistical analysis plan (SAP)
Status
Study completion date
Study design
Study documents
Study IDs
Study record
Study registry
Study results
Study start date
Study type
Title
Title acronym
U.S. Agency for Healthcare Research and Quality (AHRQ)
U.S. Food and Drug Administration (FDA)
Unknown
Skip to Main Content
ClinicalTrials.gov
Find StudiesFind Studies Menu
About StudiesAbout Studies Menu
Submit StudiesSubmit Studies Menu
ResourcesResources Menu
About SiteAbout Site Menu
HomeSearch ResultsStudy Record Detail Save this study
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.
ClinicalTrials.gov Identifier: NCT03757052
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : March 14, 2019
See Contacts and Locations
Sponsor:
CHU de Quebec-Universite Laval
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval
Study Details Tabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
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
Study Design
Go to sections
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
Drug Information available for: Penicillins Amoxicillin Amoxicillin sodium
U.S. FDA Resources
Arms and Interventions
Go to sections
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
Outcome Measures
Go to sections
Primary Outcome Measures :
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 :
Skin Tests Results [ Time Frame: 60 minutes ]
Concordance of Skin Tests Results with Oral Challenge Results
Severity of immediate hypersensitivity symptoms [ Time Frame: 60 minutes ]
Mild, moderate and severe
Delayed hypersensitivity symptoms [ Time Frame: 14 days ]
Occurrence of delayed hypersensitivity symptoms
Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
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
Contacts and Locations
Go to sections
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 ClinicalTrials.gov identifier (NCT number): NCT03757052
Contacts
Contact: Jean-Philippe Drolet, MD FRCPC 418-525-4444 jean-philippe.drolet@chudequebec.ca
Contact: Gaston De Serres, MD PhD 418-525-4444 Gaston.DeSerres@inspq.qc.ca
Locations
Canada, Quebec
CHU de Quebec Recruiting
Quebec city, Quebec, Canada
Contact: Jean-Philippe Drolet, MD
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Principal Investigator: Jean-Philippe Drolet, MD FRCPC CHU de Quebec-Universite Laval
More Information
Go to sections
Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov 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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Amoxicillin
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents
TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
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