Oral Challenge in the Pediatric ED (OPEN)
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|ClinicalTrials.gov Identifier: NCT03404804|
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Oral Challenge
Patients getting 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
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03404804
|Contact: David E Vyles, DO, MSemail@example.com|
|Contact: Duke Wagner|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Duke Wagner, D.C., CCRC 414-266-2623|