<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408508</url>
  </required_header>
  <id_info>
    <org_study_id>REB-19-97</org_study_id>
    <nct_id>NCT04408508</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients</brief_title>
  <official_title>Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saskatchewan Health Authority - Regina Area</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saskatchewan Health Authority - Regina Area</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of&#xD;
      the population and 20% of inpatients carry a label of penicillin allergy. However, less than&#xD;
      5%-10% of them have a confirmed allergy following comprehensive investigations. Reported&#xD;
      penicillin allergy leads to higher medical costs and excess complications and presents a&#xD;
      major challenge to antimicrobial stewardship.&#xD;
&#xD;
      There is a high demand for allergy services however penicillin allergy testing (including&#xD;
      skin testing and oral drug challenge) is not routinely available for inpatients even in major&#xD;
      centres. Direct oral amoxicillin challenges are safe and effective in delabeling low risk&#xD;
      patients who report penicillin allergy in large paediatric and adult studies and does not&#xD;
      necessitate specialist referral.&#xD;
&#xD;
      The study team seeks to determine the safety and efficacy of a single-dose oral penicillin&#xD;
      challenge pilot program in adult in-patients with self-reported penicillin allergy admitted&#xD;
      to hospital under the internal medicine Clinical Teaching Unit (CTU). The study investigators&#xD;
      will determine the number of patients successfully delabelled of their &quot;penicillin allergy&quot;&#xD;
      prior to discharge from hospital over a 12 month period. The study doctors will also assess&#xD;
      the economic impact of the investigator's model and ease of implementation in the busy&#xD;
      inpatient setting. In the future this model could be implemented generally as an inpatient or&#xD;
      outpatient penicillin allergy program where low risk patients, who do not require referral to&#xD;
      an allergist, are expeditiously delabelled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of&#xD;
      the population and 20% of inpatients carry a label of penicillin allergy. However, only&#xD;
      &lt;5%-10% of them have a confirmed allergy following comprehensive investigations. Reported&#xD;
      penicillin allergy leads to higher medical costs and excess complications and presents a&#xD;
      major challenge to antimicrobial stewardship. There is a high demand for allergy services&#xD;
      however penicillin allergy testing (including skin testing and oral drug challenge) is not&#xD;
      routinely available for inpatients even in major centres. Consequently, patients with a&#xD;
      penicillin allergy label receive alternative antibiotics such as carbapenems,&#xD;
      fluoroquinolones, and vancomycin for the treatment of common and serious infections and for&#xD;
      pre-surgical prophylaxis. Patients with penicillin allergy label have longer hospital stays&#xD;
      and higher rates of infections with Clostridioides (Clostridium) difficile, VRE and MRSA in&#xD;
      comparison with patients without a documented allergy.&#xD;
&#xD;
      Direct oral amoxicillin challenges are safe and effective in delabeling patients stratified&#xD;
      as low risk for penicillin allergy in large pediatric and adult studies. Low-risk penicillin&#xD;
      allergy histories include patients who have had isolated nonallergic symptoms (eg,&#xD;
      gastrointestinal symptoms) or patients solely with a family history of a penicillin allergy,&#xD;
      pruritus without rash, or remote (&gt;10 years) unknown reactions without features suggestive of&#xD;
      an IgE-mediated reaction.&#xD;
&#xD;
      The study investigators seek to determine the safety and efficacy of a single-dose oral&#xD;
      penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy&#xD;
      admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). Identified&#xD;
      patients that fulfill the exclusion and inclusion criteria will be reviewed at the time of&#xD;
      discharge for suitability, as per the algorithm, modelled after a previous study of similar&#xD;
      design. Based on patient's reported allergy, and upon obtaining informed consent,&#xD;
      participants will receive a supervised challenge of amoxicillin 250 mg once orally and&#xD;
      subsequently observed for 1 hour before discharge home. After antibiotic challenge, patient&#xD;
      outcome will be defined as (1) tolerated oral challenge with no adverse drug reaction or (2)&#xD;
      adverse drug reaction.&#xD;
&#xD;
      By challenging carefully selected low risk patient that are unlikely to be truly allergic&#xD;
      while in hospital, the study doctors can delabel patients of their &quot;penicillin allergy&quot; and&#xD;
      as a result cut health care expenditures and promote good antimicrobial stewardship. In the&#xD;
      future this model could be implemented generally as an inpatient or outpatient penicillin&#xD;
      allergy program where low risk patients, who do not require referral to an allergist, are&#xD;
      expeditiously delabeled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 2023</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients reporting penicillin allergy will be enrolled based on eligibility criteria for direct oral amoxicillin challenge. There will be one treatment group of patients assigned low risk for penicillin allergy.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients tolerating oral amoxicillin challenge</measure>
    <time_frame>12 months</time_frame>
    <description>The number of patients tolerating a single dose oral amoxicillin (250 mg) challenge without adverse reaction(s) up to one hour of administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients reporting a delayed reaction to amoxicillin</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients reporting a delayed reaction to amoxicillin (between 1 hour - 12 weeks) following observation and discharge from hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average delay in discharge attributable to amoxicillin challenge</measure>
    <time_frame>12 months</time_frame>
    <description>Average delay in discharge (minutes) attributable to penicillin challenge, recorded by the resident or staff physician performing the questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients excluded from the study due to staff time constraints</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients excluded from the study due to resident/staff time constraints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of immediate reaction attributed to the oral amoxicillin: maculopapular rash, urticaria, angioedema, airway compromise, diarrhea, vomiting or other (including subjective symptoms)</measure>
    <time_frame>12 months</time_frame>
    <description>Nature of immediate adverse reaction if challenge unsuccessful</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Penicillin Allergy</condition>
  <arm_group>
    <arm_group_label>Amoxicillin administration</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Oral amoxicillin administered to study patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin 250 MG</intervention_name>
    <description>Low dose oral amoxicillin will be administered to patients enrolled in the study meeting the inclusion and exclusion criteria.</description>
    <arm_group_label>Amoxicillin administration</arm_group_label>
    <other_name>Amoxicillin 250 mg Capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Assessed to be low risk of having a penicillin allergy as per the risk stratification&#xD;
             questionnaire&#xD;
&#xD;
          2. One of the following: i) An unknown reaction &gt;10 years before, ii) A type A adverse&#xD;
             drug reaction (pharmacologically predictable drug side effect or intolerance), or iii)&#xD;
             A history of a benign childhood rash, nonurticarial rash, or maculopapular exanthem&#xD;
             more than 10 years ago&#xD;
&#xD;
          3. Age 18 years or older&#xD;
&#xD;
          4. Hemodynamically stable and suitable for discharge home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Declines participation in the study&#xD;
&#xD;
          2. Cognitive impairment and where a collateral history could not be obtained&#xD;
&#xD;
          3. History of anaphylaxis or angioedema attributed to a penicillin-based antibiotic&#xD;
&#xD;
          4. History of severe cutaneous adverse reactions attributed to a penicillin-based&#xD;
             antibiotic&#xD;
&#xD;
          5. History of acute kidney injury or severe liver impairment attributed to a&#xD;
             penicillin-based antibiotic&#xD;
&#xD;
          6. Currently taking an angiotensin-converting enzyme inhibitor, angiotensin-receptor&#xD;
             blocker or a beta blocker&#xD;
&#xD;
          7. Hemodynamically unstable&#xD;
&#xD;
          8. History of idiopathic urticaria or idiopathic anaphylaxis&#xD;
&#xD;
          9. Currently taking an antibiotic(s) for treatment of an active infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Fong, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saskatchewan Health Authority - Regina Area</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarah Lohrenz, MD</last_name>
    <phone>13067156011</phone>
    <email>skl621@usask.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Fong, MD, FRCPC</last_name>
    <phone>13062061291</phone>
    <email>andrea.fong@usask.ca</email>
  </overall_contact_backup>
  <reference>
    <citation>Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010 Oct;105(4):259-273. doi: 10.1016/j.anai.2010.08.002.</citation>
    <PMID>20934625</PMID>
  </reference>
  <results_reference>
    <citation>Macy E. Penicillin allergy: optimizing diagnostic protocols, public health implications, and future research needs. Curr Opin Allergy Clin Immunol. 2015 Aug;15(4):308-13. doi: 10.1097/ACI.0000000000000173.</citation>
    <PMID>26110680</PMID>
  </results_reference>
  <results_reference>
    <citation>Macy E, Ngor EW. Safely diagnosing clinically significant penicillin allergy using only penicilloyl-poly-lysine, penicillin, and oral amoxicillin. J Allergy Clin Immunol Pract. 2013 May-Jun;1(3):258-63. doi: 10.1016/j.jaip.2013.02.002. Epub 2013 Apr 6.</citation>
    <PMID>24565482</PMID>
  </results_reference>
  <results_reference>
    <citation>Mohamed OE, Beck S, Huissoon A, Melchior C, Heslegrave J, Baretto R, Ekbote A, Krishna MT. A Retrospective Critical Analysis and Risk Stratification of Penicillin Allergy Delabeling in a UK Specialist Regional Allergy Service. J Allergy Clin Immunol Pract. 2019 Jan;7(1):251-258. doi: 10.1016/j.jaip.2018.05.025. Epub 2018 Jun 5.</citation>
    <PMID>29883754</PMID>
  </results_reference>
  <results_reference>
    <citation>Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin &quot;allergy&quot; in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014 Mar;133(3):790-6. doi: 10.1016/j.jaci.2013.09.021. Epub 2013 Nov 1.</citation>
    <PMID>24188976</PMID>
  </results_reference>
  <results_reference>
    <citation>Mill C, Primeau MN, Medoff E, Lejtenyi C, O'Keefe A, Netchiporouk E, Dery A, Ben-Shoshan M. Assessing the Diagnostic Properties of a Graded Oral Provocation Challenge for the Diagnosis of Immediate and Nonimmediate Reactions to Amoxicillin in Children. JAMA Pediatr. 2016 Jun 6;170(6):e160033. doi: 10.1001/jamapediatrics.2016.0033. Epub 2016 Jun 6.</citation>
    <PMID>27043788</PMID>
  </results_reference>
  <results_reference>
    <citation>Tucker MH, Lomas CM, Ramchandar N, Waldram JD. Amoxicillin challenge without penicillin skin testing in evaluation of penicillin allergy in a cohort of Marine recruits. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):813-815. doi: 10.1016/j.jaip.2017.01.023. Epub 2017 Mar 21. No abstract available.</citation>
    <PMID>28341170</PMID>
  </results_reference>
  <results_reference>
    <citation>Labrosse R, Paradis L, Lacombe-Barrios J, Samaan K, Graham F, Paradis J, Begin P, Des Roches A. Efficacy and Safety of 5-Day Challenge for the Evaluation of Nonsevere Amoxicillin Allergy in Children. J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1673-1680. doi: 10.1016/j.jaip.2018.01.030. Epub 2018 Feb 7.</citation>
    <PMID>29425903</PMID>
  </results_reference>
  <results_reference>
    <citation>Iammatteo M, Alvarez Arango S, Ferastraoaru D, Akbar N, Lee AY, Cohen HW, Jerschow E. Safety and Outcomes of Oral Graded Challenges to Amoxicillin without Prior Skin Testing. J Allergy Clin Immunol Pract. 2019 Jan;7(1):236-243. doi: 10.1016/j.jaip.2018.05.008. Epub 2018 May 23.</citation>
    <PMID>29802906</PMID>
  </results_reference>
  <results_reference>
    <citation>Ibanez MD, Rodriguez Del Rio P, Lasa EM, Joral A, Ruiz-Hornillos J, Munoz C, Gomez Traseira C, Escudero C, Olaguibel Rivera JM, Garriga-Baraut T, Gonzalez-de-Olano D, Rosado A, Sanchez-Garcia S, Perez Bustamante S, Padial Vilchez MA, Prieto Montano P, Candon Morillo R, Macias Iglesia E, Feliu Vila A, Valbuena T, Lopez-Patino A, Martorell A, Sastre J, Audicana MT; Penicillin Allergy in Children (APENIN) Task Force. Pediatric Allergy Committee, Spanish Society of Allergy and Clinical Immunology (SEAIC). Prospective assessment of diagnostic tests for pediatric penicillin allergy: From clinical history to challenge tests. Ann Allergy Asthma Immunol. 2018 Aug;121(2):235-244.e3. doi: 10.1016/j.anai.2018.05.013. Epub 2018 May 25.</citation>
    <PMID>29803713</PMID>
  </results_reference>
  <results_reference>
    <citation>Confino-Cohen R, Rosman Y, Meir-Shafrir K, Stauber T, Lachover-Roth I, Hershko A, Goldberg A. Oral Challenge without Skin Testing Safely Excludes Clinically Significant Delayed-Onset Penicillin Hypersensitivity. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):669-675. doi: 10.1016/j.jaip.2017.02.023.</citation>
    <PMID>28483317</PMID>
  </results_reference>
  <results_reference>
    <citation>Banks TA, Tucker M, Macy E. Evaluating Penicillin Allergies Without Skin Testing. Curr Allergy Asthma Rep. 2019 Mar 22;19(5):27. doi: 10.1007/s11882-019-0854-6.</citation>
    <PMID>30903298</PMID>
  </results_reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 3, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>beta-lactam</keyword>
  <keyword>penicillin</keyword>
  <keyword>hypersensitivity</keyword>
  <keyword>drug allergy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No only agregate data will be shared</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408508
org study id: REB-19-97
nct id: NCT04408508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of
      the population and 20% of inpatients carry a label of penicillin allergy. However, less than
      5%-10% of them have a confirmed allergy following comprehensive investigations. Reported
      penicillin allergy leads to higher medical costs and excess complications and presents a
      major challenge to antimicrobial stewardship.

      There is a high demand for allergy services however penicillin allergy testing (including
      skin testing and oral drug challenge) is not routinely available for inpatients even in major
      centres. Direct oral amoxicillin challenges are safe and effective in delabeling low risk
      patients who report penicillin allergy in large paediatric and adult studies and does not
      necessitate specialist referral.

      The study team seeks to determine the safety and efficacy of a single-dose oral penicillin
      challenge pilot program in adult in-patients with self-reported penicillin allergy admitted
      to hospital under the internal medicine Clinical Teaching Unit (CTU). The study investigators
      will determine the number of patients successfully delabelled of their "penicillin allergy"
      prior to discharge from hospital over a 12 month period. The study doctors will also assess
      the economic impact of the investigator's model and ease of implementation in the busy
      inpatient setting. In the future this model could be implemented generally as an inpatient or
      outpatient penicillin allergy program where low risk patients, who do not require referral to
      an allergist, are expeditiously delabelled.
Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of
      the population and 20% of inpatients carry a label of penicillin allergy. However, only
      <5%-10% of them have a confirmed allergy following comprehensive investigations. Reported
      penicillin allergy leads to higher medical costs and excess complications and presents a
      major challenge to antimicrobial stewardship. There is a high demand for allergy services
      however penicillin allergy testing (including skin testing and oral drug challenge) is not
      routinely available for inpatients even in major centres. Consequently, patients with a
      penicillin allergy label receive alternative antibiotics such as carbapenems,
      fluoroquinolones, and vancomycin for the treatment of common and serious infections and for
      pre-surgical prophylaxis. Patients with penicillin allergy label have longer hospital stays
      and higher rates of infections with Clostridioides (Clostridium) difficile, VRE and MRSA in
      comparison with patients without a documented allergy.

      Direct oral amoxicillin challenges are safe and effective in delabeling patients stratified
      as low risk for penicillin allergy in large pediatric and adult studies. Low-risk penicillin
      allergy histories include patients who have had isolated nonallergic symptoms (eg,
      gastrointestinal symptoms) or patients solely with a family history of a penicillin allergy,
      pruritus without rash, or remote (>10 years) unknown reactions without features suggestive of
      an IgE-mediated reaction.

      The study investigators seek to determine the safety and efficacy of a single-dose oral
      penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy
      admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). Identified
      patients that fulfill the exclusion and inclusion criteria will be reviewed at the time of
      discharge for suitability, as per the algorithm, modelled after a previous study of similar
      design. Based on patient's reported allergy, and upon obtaining informed consent,
      participants will receive a supervised challenge of amoxicillin 250 mg once orally and
      subsequently observed for 1 hour before discharge home. After antibiotic challenge, patient
      outcome will be defined as (1) tolerated oral challenge with no adverse drug reaction or (2)
      adverse drug reaction.

      By challenging carefully selected low risk patient that are unlikely to be truly allergic
      while in hospital, the study doctors can delabel patients of their "penicillin allergy" and
      as a result cut health care expenditures and promote good antimicrobial stewardship. In the
      future this model could be implemented generally as an inpatient or outpatient penicillin
      allergy program where low risk patients, who do not require referral to an allergist, are
      expeditiously delabeled.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients reporting penicillin allergy will be enrolled based on eligibility criteria for direct oral amoxicillin challenge. There will be one treatment group of patients assigned low risk for penicillin allergy.
primary purpose: Other
masking: None (Open Label)
measure: Number of patients tolerating oral amoxicillin challenge
time frame: 12 months
description: The number of patients tolerating a single dose oral amoxicillin (250 mg) challenge without adverse reaction(s) up to one hour of administration
measure: Number of patients reporting a delayed reaction to amoxicillin
time frame: 12 months
description: Number of patients reporting a delayed reaction to amoxicillin (between 1 hour - 12 weeks) following observation and discharge from hospital
measure: Average delay in discharge attributable to amoxicillin challenge
time frame: 12 months
description: Average delay in discharge (minutes) attributable to penicillin challenge, recorded by the resident or staff physician performing the questionnaire
measure: The number of patients excluded from the study due to staff time constraints
time frame: 12 months
description: Number of patients excluded from the study due to resident/staff time constraints
measure: Type of immediate reaction attributed to the oral amoxicillin: maculopapular rash, urticaria, angioedema, airway compromise, diarrhea, vomiting or other (including subjective symptoms)
time frame: 12 months
description: Nature of immediate adverse reaction if challenge unsuccessful
arm group label: Amoxicillin administration
arm group type: Other
description: Oral amoxicillin administered to study patients
intervention type: Drug
intervention name: Amoxicillin 250 MG
description: Low dose oral amoxicillin will be administered to patients enrolled in the study meeting the inclusion and exclusion criteria.
arm group label: Amoxicillin administration
other name: Amoxicillin 250 mg Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea Fong, MD, FRCPC
role: Principal Investigator
affiliation: Saskatchewan Health Authority - Regina Area
last name: Sarah Lohrenz, MD
phone: 13067156011
email: skl621@usask.ca
last name: Andrea Fong, MD, FRCPC
phone: 13062061291
email: andrea.fong@usask.ca
citation: Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010 Oct;105(4):259-273. doi: 10.1016/j.anai.2010.08.002.
PMID: 20934625
citation: Macy E. Penicillin allergy: optimizing diagnostic protocols, public health implications, and future research needs. Curr Opin Allergy Clin Immunol. 2015 Aug;15(4):308-13. doi: 10.1097/ACI.0000000000000173.
PMID: 26110680
citation: Macy E, Ngor EW. Safely diagnosing clinically significant penicillin allergy using only penicilloyl-poly-lysine, penicillin, and oral amoxicillin. J Allergy Clin Immunol Pract. 2013 May-Jun;1(3):258-63. doi: 10.1016/j.jaip.2013.02.002. Epub 2013 Apr 6.
PMID: 24565482
citation: Mohamed OE, Beck S, Huissoon A, Melchior C, Heslegrave J, Baretto R, Ekbote A, Krishna MT. A Retrospective Critical Analysis and Risk Stratification of Penicillin Allergy Delabeling in a UK Specialist Regional Allergy Service. J Allergy Clin Immunol Pract. 2019 Jan;7(1):251-258. doi: 10.1016/j.jaip.2018.05.025. Epub 2018 Jun 5.
PMID: 29883754
citation: Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin "allergy" in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014 Mar;133(3):790-6. doi: 10.1016/j.jaci.2013.09.021. Epub 2013 Nov 1.
PMID: 24188976
citation: Mill C, Primeau MN, Medoff E, Lejtenyi C, O'Keefe A, Netchiporouk E, Dery A, Ben-Shoshan M. Assessing the Diagnostic Properties of a Graded Oral Provocation Challenge for the Diagnosis of Immediate and Nonimmediate Reactions to Amoxicillin in Children. JAMA Pediatr. 2016 Jun 6;170(6):e160033. doi: 10.1001/jamapediatrics.2016.0033. Epub 2016 Jun 6.
PMID: 27043788
citation: Tucker MH, Lomas CM, Ramchandar N, Waldram JD. Amoxicillin challenge without penicillin skin testing in evaluation of penicillin allergy in a cohort of Marine recruits. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):813-815. doi: 10.1016/j.jaip.2017.01.023. Epub 2017 Mar 21. No abstract available.
PMID: 28341170
citation: Labrosse R, Paradis L, Lacombe-Barrios J, Samaan K, Graham F, Paradis J, Begin P, Des Roches A. Efficacy and Safety of 5-Day Challenge for the Evaluation of Nonsevere Amoxicillin Allergy in Children. J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1673-1680. doi: 10.1016/j.jaip.2018.01.030. Epub 2018 Feb 7.
PMID: 29425903
citation: Iammatteo M, Alvarez Arango S, Ferastraoaru D, Akbar N, Lee AY, Cohen HW, Jerschow E. Safety and Outcomes of Oral Graded Challenges to Amoxicillin without Prior Skin Testing. J Allergy Clin Immunol Pract. 2019 Jan;7(1):236-243. doi: 10.1016/j.jaip.2018.05.008. Epub 2018 May 23.
PMID: 29802906
citation: Ibanez MD, Rodriguez Del Rio P, Lasa EM, Joral A, Ruiz-Hornillos J, Munoz C, Gomez Traseira C, Escudero C, Olaguibel Rivera JM, Garriga-Baraut T, Gonzalez-de-Olano D, Rosado A, Sanchez-Garcia S, Perez Bustamante S, Padial Vilchez MA, Prieto Montano P, Candon Morillo R, Macias Iglesia E, Feliu Vila A, Valbuena T, Lopez-Patino A, Martorell A, Sastre J, Audicana MT; Penicillin Allergy in Children (APENIN) Task Force. Pediatric Allergy Committee, Spanish Society of Allergy and Clinical Immunology (SEAIC). Prospective assessment of diagnostic tests for pediatric penicillin allergy: From clinical history to challenge tests. Ann Allergy Asthma Immunol. 2018 Aug;121(2):235-244.e3. doi: 10.1016/j.anai.2018.05.013. Epub 2018 May 25.
PMID: 29803713
citation: Confino-Cohen R, Rosman Y, Meir-Shafrir K, Stauber T, Lachover-Roth I, Hershko A, Goldberg A. Oral Challenge without Skin Testing Safely Excludes Clinically Significant Delayed-Onset Penicillin Hypersensitivity. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):669-675. doi: 10.1016/j.jaip.2017.02.023.
PMID: 28483317
citation: Banks TA, Tucker M, Macy E. Evaluating Penicillin Allergies Without Skin Testing. Curr Allergy Asthma Rep. 2019 Mar 22;19(5):27. doi: 10.1007/s11882-019-0854-6.
PMID: 30903298
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Amoxicillin
sharing ipd: No
ipd description: No only agregate data will be shared