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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 is a Phase 4 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 116 participants.
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.
Interventions
- DRUG Amoxicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2022-12-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03404804
The ClinicalTrials.gov registry entry for NCT03404804 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amoxicillin is the first listed.
NCT03404804 reports 0 study locations.
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.
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