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Anti-infective Agent

Low risk for Penicillin Allergy (DOC Trial)

N/A

Recruiting

Research Sponsored by Northern Ontario School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals who suffer from pruritus (severe itching), with or without maculopapular rash after taking Amoxicillin

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

DOC Trial Summary

This trial is evaluating a new clinic called the DOC that will be set up in Huntsville. It is for people in the Muskoka region who have a low-risk penicillin allergy. Participants will

Who is the study for?

This trial is for people in the Muskoka region with a low-risk penicillin allergy. Participants will join a clinic to challenge their allergy by taking penicillin under supervision and then provide feedback on their experience.Check my eligibility

What is being tested?

The study tests whether direct oral challenges with low and standard doses of penicillin can safely remove the allergy label from patients' records. It also examines how this change affects antibiotic use over two years.See study design

What are the potential side effects?

Possible side effects may include allergic reactions ranging from mild skin rashes to more severe responses, depending on individual sensitivity to penicillin.

DOC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience severe itching or a rash after taking Amoxicillin.

DOC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Are adequate participants available for DOC

Can a DOC operate in a rural community

Can participants be delableled through the DOC

+1 more

DOC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low riskExperimental Treatment4 Interventions

Low risk patients will participate in the DOC challenge

Group II: High riskActive Control1 Intervention

Any participant defined as more than low risk will not receive the DOC

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northern Ontario School of MedicineLead Sponsor

10 Previous Clinical Trials

822 Total Patients Enrolled

Malcolm Wilson, MDStudy DirectorMuskoka Algonquin Healthcare

Frequently Asked Questions

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

Are there currently ongoing patient enrollments for this clinical trial?

"As stated on clinicaltrials.gov, this ongoing trial is currently seeking eligible participants. The initial posting of the study occurred on October 6th, 2023 and it was last updated on January 3rd, 2024."

Answered by AI

What is the total number of individuals actively engaged in this medical study?

"Indeed, as per the details on clinicaltrials.gov, this trial is presently in the process of recruiting participants. The initial posting date was October 6th, 2023, and it has been recently updated on January 3rd, 2024. The study aims to enroll a total of 100 participants across one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of a Direct Oral Penicillin Challenge in a Rural Community

Lisa Allen 2023. "Evaluation of a Direct Oral Penicillin Challenge in a Rural Community". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06192277.