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Oral Challenge in the Pediatric ED (OPEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03404804
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
David Vyles, Medical College of Wisconsin

Brief 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 will begin as a single site feasibility study, however including up to 2 other collaborative sites for enrollment has been favorably discussed. We do not anticipate this to be a single IRB scenario and will submit a timely comprehensive amendment if plans become concrete and the initial data here proves reliable.

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.

Condition or disease Intervention/treatment Phase
Penicillin Allergy Pediatric Emergency Medicine Drug: Amoxicillin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Oral Penicillin Challenge in the Pediatric Emergency Department
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : December 4, 2018
Estimated Study Completion Date : December 4, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Oral Challenge
Patients getting amoxicillin
Drug: Amoxicillin
Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy

No Intervention: No-oral challenge
Patients randomized to not get amoxicillin

Primary Outcome Measures :
  1. Oral amoxicillin challenge [ Time Frame: 1 year ]
    Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit.

Secondary Outcome Measures :
  1. Oral amoxicillin challenge follow-up [ Time Frame: 1 year ]
    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.

  2. Cost analysis [ Time Frame: 1 year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 3-16 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,
  • pregnancy,
  • child took any antihistamine in the past three days [including diphenhydramine (Benadryl®), cetirizine (Zyrtec®), loratadine (Claritin®), fexofenadine (Allegra®), levocetirizine (Xyzal®), and desloratadine (Clarinex®)] or
  • 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 being admitted to the hospital or those who are 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03404804

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Contact: David E Vyles, DO, MS 414-337-3227
Contact: Duke Wagner

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United States, Wisconsin
David Vyles Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Duke Wagner, D.C., CCRC    414-266-2623      
Sponsors and Collaborators
Medical College of Wisconsin

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Responsible Party: David Vyles, Assistant Professor, Medical College of Wisconsin Identifier: NCT03404804     History of Changes
Other Study ID Numbers: 1069530-3
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents