Trial Outcomes & Findings for Oral Challenge in the Pediatric ED (NCT NCT03404804)

NCT ID: NCT03404804

Last Updated: 2024-05-16

Results Overview

Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit with insignificant adverse result.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 116 participants
• Primary outcome timeframe: 1 and 7 day followup phone surveys were conducted.
• Results posted on: 2024-05-16

Participant Flow

Eligible families were approached, consented, and then administered an allergy questionnaire. Research staff abstracted age and demographic characteristics from the medical record. Patients who met eligibility criteria and were deemed low-risk were offered an oral drug challenge with amoxicillin.

Here at CHW we documented 130 subjects who were only given the questionnaire to assess risk and were not oral challenged in the CHW ED. In March of 2020, the study questionnaire was adopted as standard of clinical care for any patients presenting with a history of penicillin allergy, thus the questionnaire portion of the study was no longer a research activity. However, if the assessed risk was low, patients were approached for participation in oral challenge and consented if agreeable

Participant milestones

Measure	Oral Challenge Patients getting amoxicillin Amoxicillin: Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy
Overall Study STARTED	116
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Challenge in the Pediatric ED

Baseline characteristics by cohort

Measure	Oral Challenge n=116 Participants Patients getting amoxicillin Amoxicillin: Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy
Age, Categorical <=18 years	116 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	9 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Race/Ethnicity, Customized white	67 Participants n=5 Participants
Race/Ethnicity, Customized African American	25 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	15 Participants n=5 Participants
Race/Ethnicity, Customized unknown	9 Participants n=5 Participants
Region of Enrollment United States	116 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 and 7 day followup phone surveys were conducted.

Population: Subjects who met inclusion/exclusion criteria, were confirmed to be low risk and agreed to be oral challenged.

Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit with insignificant adverse result.

Outcome measures

Measure	Oral Challenge n=116 Participants Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy
Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result Number of subjects who tolerated an oral challenge without demonstrating allergy.	114 Participants
Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result Children who had mild symptoms after challenge deemed to be an allergic reaction.	2 Participants

SECONDARY outcome

Timeframe: 6 months and 12 months after oral challenge

Population: Determined to be eligible by risk survey and giving consent to participate.

Conduct follow-up 6 months and 12 months after oral challenge for all children after oral challenge for patients discharged with a prescription antibiotic to determine if a delayed or T-Cell mediated reaction occurs after exposure to multiple doses of penicillin or any other antibiotic prescribed at discharge.

Outcome measures

Measure	Oral Challenge n=116 Participants Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy
Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure Number of subjects who developed allergy symptoms.	2 Participants
Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure number of children who tolerated an oral amoxicillin challenge	114 Participants

Adverse Events

Oral Challenge

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oral Challenge n=116 participants at risk Patients getting Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy. Two children (1.7%) had mild symptoms after challenge deemed consistent with an allergic reaction by the PED provider. Four children experienced mild symptoms deemed not related to an allergic reaction by the examining physician
Skin and subcutaneous tissue disorders mild symptoms not related to allergic reaction to oral challenge	1.7% 2/116 • Number of events 2 • 1 year after oral challenge.

Additional Information

Dr. David Vyles, DO

Medical College of Wisconsin

Phone: 414-266-2625

Email: dvyles@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place