Phase 4 N=40 Other

Inpatient Penicillin Allergy Delabeling Study

Penicillin Allergy · Penicillin Sensitivity · Penicillin Reaction · Penicillin Intolerance

Bottom Line

View on ClinicalTrials.gov: NCT05020327 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Number of Participants With Confirmed Allergy Status — 28; 6; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Graded Oral Amoxicillin Challenge (Drug); De-labelling in electronic medical record (Other); Referral to Allergy Immunology/Retention of Allergy Label (Other)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: University Hospitals Cleveland Medical Center
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Confirmed Allergy Status	28; 6; 6	—
SECONDARY Number of Participants With no Penicillin Allergy Confirmed and De-labelled of Penicillin Allergy Based on Results of Questionnaire.	11; 5; 0	—
SECONDARY Number of Participants Categorized as Low Risk for Penicillin Allergy Reaction With Confirmed True Penicillin Allergy as Measured by Failed Oral Amoxicillin Challenge	1; 0; 0	—
SECONDARY Number of Participants With Confirmed True Allergy Without Challenge	0; 0; 6	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05020327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.