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Penicillin De-labeling in the Pediatric Primary Care Setting

Phase 4
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-14 months after amoxicillin challenge
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking at the feasibility of delabeling patients who have a reported penicillin allergy in a pediatric primary care clinic.

Eligible Conditions
  • Penicillin Allergy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-14 months after amoxicillin challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-14 months after amoxicillin challenge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge

Side effects data

From 2023 Phase 4 trial • 23 Patients • NCT05010304
9%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pediatric Patients With a History of Penicillin Allergy

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pediatric Patients with a history of penicillin allergyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin
2017
Completed Phase 4
~7780

Find a Location

Who is running the clinical trial?

American College of Allergy, Asthma and ImmunologyOTHER
3 Previous Clinical Trials
31 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,660 Total Patients Enrolled

Media Library

Amoxicillin Clinical Trial Eligibility Overview. Trial Name: NCT05010304 — Phase 4
Penicillin Allergy Research Study Groups: Pediatric Patients with a history of penicillin allergy
Penicillin Allergy Clinical Trial 2023: Amoxicillin Highlights & Side Effects. Trial Name: NCT05010304 — Phase 4
Amoxicillin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010304 — Phase 4
~6 spots leftby Dec 2025
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