TerminatedPhase 4

Oral Penicillin Challenge and Allergy De-labeling in Children

Stopped: Unable to recruit sufficient number of subjects in the setting

United States31 participantsStarted 2022-09-26

Plain-language summary

The primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. The secondary purpose is to evaluate the safety and feasibility of administering oral penicillin allergy challenges in the Pediatric Emergency Department.

Who can participate

Age range2 Years – 17 Years

SexALL

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Inclusion criteria

✓. Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies)
✓. Patients at low risk of anaphylaxis as determined by the study questionnaire
✓. Patients who would normally be prescribed amoxicillin, amoxicillin-clavulanate or another penicillin for their current bacterial infection, including otitis media, Group A Streptococcal pharyngitis, pneumonia. sinusitis, dog and cat bite wounds, regimens for Helicobacter pylori eradication, or other acute infections deemed susceptible.
✓. Patients who are interested in participating
✓. Patients who have an acceptable surrogate to give consent on the subject's behalf
✓. Patients whose surrogate (parent/caregiver) speaks English or Spanish

Exclusion criteria

✕. Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate
✕. Patients who have multiple drug allergies

What they're measuring

True Penicillin Allergies

Timeframe: 24 hours after amoxicillin oral challenge

Trial details

NCT IDNCT05563610

SponsorPhoenix Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-12

View on ClinicalTrials.gov More Penicillin Allergy trials