Inpatient Penicillin Allergy Delabeling Study
Condition: Penicillin Allergy; Penicillin Sensitivity; Penicillin Reaction; Penicillin Intolerance
MeSH terms: Hypersensitivity; Drug Hypersensitivity
Intervention: Graded Oral Amoxicillin Challenge; De-labelling in electronic medical record; Referral to Allergy Immunology/Retention of Allergy Label
Intervention description: Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval; Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.; Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
Intervention MeSH terms: Amoxicillin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients will be screened by questionnaire to determine No risk, Low risk, or High Risk for penicillin allergic reaction. Those that are deemed Low Risk based on questionnaire, will be subsequently challenged with graded oral amoxicillin challenge.
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Penicillin allergy; Penicillin delabeling

Summary:

      The study will identify pediatric patients 3-18 years old who have penicillin allergy label
      in the electronic medical record. Those who are identified will be stratified into no-risk,
      low-risk and high-risk category using a screening questionnaire. The following definitions
      will be followed:

      No-risk: Patients who are historically labeled with penicillin allergy in the EMR based on
      family history alone OR those who have tolerated penicillin after a concerning incident
      without any reaction OR with penicillin allergy label but deny any history of reaction to any
      form of penicillin on screening questionnaire

      Low-risk: Patients with previous reaction not suggestive of anaphylaxis (defined below) AND
      not requiring hospitalization for the reaction OR reaction considered non- immunologic (e.g.
      diarrhea, nausea, yeast vaginitis) OR exposure to penicillin- containing antibiotic after the
      date of reported reaction with no anaphylaxis and hospitalization AND no serious types of
      delayed reactions such as Steven- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),
      acute interstitial nephritis (AIN), drug-induced hepatitis or other documented organ injury,
      drug rash eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia,
      and serum sickness. Patients who had delayed reaction (onset more than 24 hours) of isolated,
      non-progressive symptoms (such as rash/hives alone) also belong to this group.

      High-risk: Patients with penicillin allergy label on EMR with previous reaction suggestive of
      anaphylaxis (defined below) OR requiring hospitalization/epinephrine administration for the
      reaction OR reactions considered immunologic (angioedema, joint pains) OR involving serious
      types of reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),
      acute interstitial nephritis (AIN), drug-induced hepatitis or other documented organ injury,
      drug rash eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia,
      and serum sickness. Patients who were previously diagnosed with penicillin allergy by an
      allergist also belong to the high-risk group.

      Patients in the no-risk group will be immediately delabeled. Patients in the high-risk group
      will be referred to allergy/immunology for further work up. The focus of this study is to
      identify the patients who belong to the low-risk group. This group of patients will be
      subjected to graded oral amoxicillin challenge testing. Those who will have reactions
      compatible with allergy will have their allergy status retained in the electronic medical
      record. Those that will not have reactions or those that will have reactions that are not
      compatible with allergy will be delabeled in the electronic medical record.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria for screening

          -  Patients 3-18 years old admitted at our institution with penicillin allergy label in
             electronic medical record

          -  Patients with available parent/s or legal guardian who can give both written and
             verbal consent to the oral challenge testing

          -  Patients with available parent/s or legal guardian during the conduct of oral
             amoxicillin challenge testing

        Inclusion Criteria for oral challenge test

        - Patients who will be identified as low-risk patients based on the standardized screening
        questionnaire. Low-risk group patients are those patients with previous reaction not
        suggestive of anaphylaxis AND not requiring hospitalization for the reaction OR reaction
        considered non-immunologic (e.g. diarrhea, nausea, yeast vaginitis) OR exposure to
        penicillin-containing antibiotic after the date of reported reaction with no anaphylaxis
        and hospitalization AND no serious types of delayed reactions such as Steven-Johnson
        syndrome (SJS), toxic epidermal necrolysis (TEN), acute interstitial nephritis (AIN),
        drug-induced hepatitis or other documented organ injury, drug rash eosinophilia systemic
        symptoms (DRESS), hemolytic anemia, drug-induced cytopenia, and serum sickness. - ----
        Patients who had delayed reaction (onset more than 24 hours) of isolated, non-progressive
        symptoms (such as rash/hives alone) also belong to this group.

        Exclusion Criteria:

        Exclusion Criteria for screening

          -  Patients who cannot tolerate amoxicillin/penicillin by enteral route.

          -  Patients with no parents or legal guardian available to give both written and verbal
             consent to the oral challenge testing

          -  Patients with no available parents or legal guardian during the conduct of oral
             amoxicillin challenge testing

          -  Patients currently on antihistamine or have received antihistamine in the previous 48
             hours

          -  Patients who are critically ill

          -  Patients who have been vomiting more than twice in the past 24 hours or are actively
             vomiting

          -  Patients with respiratory symptoms warranting oxygen therapy or pulmonary finding of
             wheezing or stridor

          -  Patients identified as having anaphylactic reaction to penicillin in the electronic
             medical record

        Exclusion Criteria for oral challenge testing

          -  Patients who will be identified as no-risk patients based on the standardized
             screening questionnaire. No-risk group patients are those patients who are
             historically labeled with penicillin allergy in the EMR based on family history alone
             OR those who have tolerated penicillin after a concerning incident without any
             reaction OR with penicillin allergy label but deny any history of reaction to any form
             of penicillin on screening questionnaire

          -  Patients who will be identified as high-risk patients based on the standardized
             screening questionnaire. High-risk group patients are those patients with penicillin
             allergy label on EMR with previous reaction suggestive of anaphylaxis OR requiring
             hospitalization/epinephrine administration for the reaction OR reactions considered
             immunologic (angioedema, joint pains) OR involving serious types of reactions such as
             Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute interstitial
             nephritis (AIN), drug-induced hepatitis or other documented organ injury, drug rash
             eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia, and
             serum sickness. Patients who were previously diagnosed with penicillin allergy by an
             allergist also belong to the high-risk group.