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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 more

Awards & 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

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