Oral Challenge in the Pediatric ED

Penicillin Allergy Clinical Trial

— OPEN  

Official title:

Oral Penicillin Challenge in the Pediatric Emergency Department

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03404804
• Other study ID #: 1069530-3
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 4, 2017
• Est. completion date: December 4, 2021

Study information

• Verified date: April 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our primary objective is to demonstrate the feasibility of utilizing a novel penicillin allergy questionnaire in the PED to identify a low-risk group of patients who will complete an oral challenge in the PED to test for an IgE-mediated allergic reaction. This project began as a single site feasibility study, however it has now transitioned to include 2 other collaborative sites for enrollment. We have entered into a single IRB with 1 of the collaborative sites. The other site has elected to do their own IRB. Our secondary objective is to examine whether health care outcomes and prescription-related costs are comparable between children who are de-labeled as penicillin allergic after an oral challenge compared to a standard of care group who are not challenged in the PED.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 4, 2021
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Children aged 2-16 with a parent/guardian (hereafter termed parent) reported history of allergy to a penicillin antibiotic in which the reported allergic reaction occurred at least six months prior to the current PED visit.
• Only children well enough to be discharged to home at the conclusion of the PED visit are eligible.

Exclusion Criteria:

• Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal).
• Any contraindication to allergy testing will also result in exclusion
• (i.e. history of a severe allergic reaction to skin tests,,
• anaphylaxis in the past six weeks,
• known pregnancy
• child has a history of a condition that requires a beta blocker medicine for cardiac conditions, high blood pressure, migraine headaches, or eye drops for glaucoma (e.g. propranolol, metoprolol, atenolol and Timoptic®, or Betoptic® eye drops).
• Children who present to the PED with a rash, vomiting or current asthma symptoms including coughing, wheezing or breathing problems will also be excluded to ensure these do not mask reactions to an oral challenge.
• Patients deemed too acutely ill for participation (triage level 1 or 2 or as determined by the ED patient care team) will be excluded from the study.
• During this pilot study, we will exclude non-English speaking families. However, in subsequent studies we will include the non-English speaking population.
• Children who are wards of the state, in foster care or police custody or detention will be excluded.
• Children with any basal condition (trauma, infection, minor accidents, etc..) will be able to participate in the study provided they and their family are willing and do not meet the above-mentioned exclusion criteria.

Related Conditions & MeSH terms

• Emergencies
• Pediatric Emergency Medicine
• Penicillin Allergy

Intervention

Drug:
• Amoxicillin
Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy

Locations

Country	Name	City	State
United States	David Vyles	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral amoxicillin challenge	Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit.	1 year
Secondary	Oral amoxicillin challenge follow-up	Conduct follow-up one day after oral challenge for all children and seven days 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.	1 year
Secondary	Cost analysis	Examine whether health care outcomes and prescription-related costs associated with illness treatment plans are comparable between children who are de-labeled as penicillin allergic after an oral challenge compared to a standard of care group who are not challenged in the pediatric emergency department.	1 year