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Amoxicillin for Penicillin Allergy
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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10-14 months after amoxicillin challenge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-14 months after amoxicillin challenge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjects stratified as low-risk with a negative immediate amoxicillin challenge in the pediatric primary care setting
Subjects who complete risk-stratification of penicillin allergy in the pediatric primary care setting
Secondary outcome measures
Penicillin allergy labeling in subjects with negative amoxicillin challenge
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
1,055 Previous Clinical Trials
1,054,846 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Pediatric Patients with a history of penicillin allergy
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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