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Anti-bacterial

One-dose group 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of successfully "delabeled" subjects in one-dose versus two-dose groups

Secondary outcome measures

Analysis of adverse reactions

Analysis of demographic data

Analysis of medical and allergic history

+1 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

James Tarbox, MDLead Sponsor

Texas Tech University Health Sciences CenterOTHER

104 Previous Clinical Trials

10,394 Total Patients Enrolled

James A Tarbox, MDPrincipal InvestigatorTexas Tech University Health Sciences Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 70 and above eligible to participate in this research study?

"Individuals aged 18 to 89 are eligible for participation in this trial based on the specified age criteria."

Answered by AI

Is this medical trial currently accepting new participants?

"Indeed, the details on clinicaltrials.gov confirm that this investigation is currently in search of suitable candidates. Initially shared on 2nd March 2024 and updated lastly on 3rd April 2024, it aims to enroll a total of 380 participants from one designated site."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, information on clinicaltrials.gov confirms that recruitment is ongoing for this trial. The study was originally posted on February 3rd, 2024 and last modified on March 4th, 2024. A total of 380 participants are sought at a single research site."

Answered by AI

Is the One-dose group considered a safe option for patients?

"According to our assessments at Power, the safety rating for the single-dose group in this Phase 3 trial is a top score of 3. This reflects existing efficacy data and thorough safety evaluations over multiple phases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge

James Tarbox, MD 2024. "Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06303128.

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