Drug Allergy, Penicillin
Conditions
Brief summary
This study seeks to enroll patients admitted to a children's hospital with identified penicillin allergy. A screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patient's with drug allergies.
Detailed description
This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion.
Interventions
PROCEDUREDirect Oral Challenge
Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose
Sponsors
University of Tennessee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Patients \>2 years * Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy
Exclusion criteria
* Female patients aged \>8 years of age * Patients with hemodynamic instability * Patients identified with moderate or high risk histories per protocol * Patients currently taking oral antihistamines in 48 hours prior to direct challenge * Patients currently taking oral steroids in 48 hours prior to direct challenge * Patients currently receiving medications for nausea, shortness of breath,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Direct Oral Challenge | 2 hours | Pass or Failure of direct oral challenge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up at 48 | 48 hours | Follow-up phone call to assess adverse reaction by 48 hours. Data to be collected by screening questionnaire to assess for reactions such as fever, rash, manufacturer labeled adverse side effects. |
| Follow-up at 6 months | 6 months | Follow-up phone call to assess subsequent tolerance or reaction of penicillin based antibiotic if prescribed in this time period. Data to be collected by screening questionnaire. |
Countries
United States
Outcome results
None listed