Penicillin Allergy Clinical Trial
Official title:
Inpatient Penicillin Allergy Delabeling Pilot Project at University Hospitals-Rainbow Babies and Children's Hospital in Cleveland, Ohio
Verified date | June 2023 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 30, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Rainbow Babies and Children's Hospital | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Confirmed Allergy Status | Participants with penicillin allergy status verification based on questionnaire and challenge | 3 hours | |
Secondary | Number of Participants With no Penicillin Allergy Confirmed and De-labelled of Penicillin Allergy Based on Results of Questionnaire. | Identification and delabeling of patients with no-risk status. These are the patients with no grounded history of reaction compatible with allergic reaction. | 3 hours | |
Secondary | Number of Participants Categorized as Low Risk for Penicillin Allergy Reaction With Confirmed True Penicillin Allergy as Measured by Failed Oral Amoxicillin Challenge | Identification of patients who are low-risk with verified true allergy triggering referral to allergy immunology | 3 hours | |
Secondary | Number of Participants With Confirmed True Allergy Without Challenge | Identification of patients who are high risk. These are patients identified with history of reactions compatible with true allergy. Those who are not following with allergy can be given proper referral for further evaluation and management. | 3 hours |
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