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Anti-bacterial
Amoxicillin Challenge for Penicillin Allergy
Phase 3
Recruiting
Led By James A Tarbox, MD
Research Sponsored by James Tarbox, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial
Summary
This trial aims to determine if adults who were previously labeled as "penicillin-allergic" but are at low risk of having an allergic reaction can safely have their penicillin allergy label removed.
Who is the study for?
This trial is for adults previously labeled as 'penicillin-allergic' but are considered low-risk for an actual allergic reaction. They will be given amoxicillin to see if their allergy label can be safely removed.
What is being tested?
The study tests whether a single dose of oral amoxicillin is as safe and effective in delabeling penicillin allergy as a two-dose challenge, with participants monitored for any allergic reactions.
What are the potential side effects?
Potential side effects may include symptoms of an allergic reaction such as rash, itching, breathing difficulties or other signs that would indicate intolerance to the administered drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of successfully "delabeled" subjects in one-dose versus two-dose groups
Secondary study objectives
Analysis of adverse reactions
Analysis of demographic data
Analysis of medical and allergic history
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: One-dose groupExperimental Treatment2 Interventions
Patients assigned to this group will receive a liquid placebo followed by full-dose liquid amoxicillin 250mg PO thirty minutes later.
Group II: Graded, two-dose groupActive Control2 Interventions
Patients assigned to this group will receive liquid amoxicillin (25% of 250mg dose), followed by liquid amoxicillin 187.5mg PO (75% of 250mg dose) thirty minutes later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Texas Tech University Health Sciences CenterOTHER
105 Previous Clinical Trials
10,603 Total Patients Enrolled
James Tarbox, MDLead Sponsor
James A Tarbox, MDPrincipal InvestigatorTexas Tech University Health Sciences Center