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Oral Amoxicillin Challenge for Penicillin Allergy in Children

Phase 4

Recruiting

Led By Diane E Hindman, MD PharmD

Research Sponsored by Phoenix Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after amoxicillin oral challenge

Awards & highlights

Study Summary

This trial is investigating how many children who are labeled as allergic to penicillin are actually allergic, and whether it's safe to give them penicillin in the Emergency Department.

Who is the study for?

This trial is for children aged 2-17 who are in the pediatric emergency department, labeled as penicillin-allergic but at low risk of anaphylaxis. They should need amoxicillin for a current infection and have a parent or caregiver to consent. Children with multiple drug allergies or disinterest from them or their caregivers cannot participate.Check my eligibility

What is being tested?

The study aims to challenge the accuracy of penicillin allergy labels in children by giving them oral amoxicillin and observing reactions. It will also assess if this can be safely done in the Pediatric Emergency Department.See study design

What are the potential side effects?

Possible side effects may include allergic reactions ranging from mild skin rashes to more severe responses; however, only kids at low risk of serious allergy (anaphylaxis) are included to minimize risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after amoxicillin oral challenge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after amoxicillin oral challenge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after amoxicillin oral challenge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Penicillins

Secondary outcome measures

Amoxicillin

Amoxicillin Oral Challenge Safety - Admissions

Amoxicillin

+2 more

Side effects data

From 2022 Phase 4 trial • 40 Patients • NCT05020327

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Low Risk Patients

No Risk Patients

High Risk

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Oral ChallengeExperimental Treatment1 Intervention

Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge.

Group II: No Oral ChallengeActive Control1 Intervention

Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to no oral amoxicillin 500 mg challenge..

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amoxicillin 500mg

2018

Completed Phase 4

~360

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor

74 Previous Clinical Trials

5,013,715 Total Patients Enrolled

Diane E Hindman, MD PharmDPrincipal InvestigatorEmergency Department Attending Physician

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots open for individuals to take part in this experiment?

"Clinicaltrials.gov states that this medical trial is no longer taking on new candidates, as the study was last revised on September 29th 2022. Nevertheless, 256 other trials are currently recruiting participants."

Answered by AI

Is this research undertaking accessible to elderly participants?

"To participate in this research, minors aged between 2 and 17 must meet the inclusion criteria. There are 82 clinical trials for youths and 156 specifically designed for seniors above 65 years of age."

Answered by AI