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NCT03404804 · ClinicalTrials.gov registry record · Phase 4

Oral Challenge in the Pediatric ED

A Phase 4 study, sponsored by Medical College of Wisconsin.

Completed
Registry status
Phase 4
Development phase
116
Enrollment target

NCT03404804: Completed Phase 4 study, sponsored by Medical College of Wisconsin.

NCT03404804 is a Phase 4 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 116 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03404804, a Phase 4 study, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
Phase 4
Development phase
116 participants
Enrollment target

Study Summary

Our primary objective was 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 was a 3-site pediatric emergency department study in which we challenged patients who met specific inclusion and exclusion criteria and were deemed low-risk. Original aims included: Aim 1: Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit. Aim 2: 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. Aim 3: Examine health care outcomes and prescription-related costs associated with illness treatment plans in children who are de-labeled as penicillin allergic after an oral challenge. A secondary objective within the IRB protocol reports, "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." However, we never proceeded with enrolling patients with PCN allergy not challenged in the PED as it was planned for later in the study that did not come to fruition.

Primary Outcome

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.

Interventions

  • DRUG Amoxicillin

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2017-12-04
Est. Completion 2022-12-04
Phase Phase 4
Medical College of Wisconsin

447 total trials

What the finished NCT03404804 record still lists

NCT03404804 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 1 intervention - of which Amoxicillin is the first listed.

NCT03404804 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03404804 about?

NCT03404804 is a clinical study titled "Oral Challenge in the Pediatric ED". Our primary objective was 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 was a 3-site pediatric emergency depar...

What is the current status of trial NCT03404804?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 116 participants. The study started on 2017-12-04. Estimated completion is 2022-12-04.

What interventions are being tested in trial NCT03404804?

The interventions under investigation include: Amoxicillin (DRUG).

Who is sponsoring clinical trial NCT03404804?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03404804's enrollment target sits among peer trials

116 714th of 2000 higher than 1,283 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03404804, the US trial registry maintained by the National Library of Medicine. NCT03404804 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.