Evaluation of a Direct Oral Penicillin Challenge in a Rural Community (DOC)

January 3, 2024 updated by: Lisa Allen, Northern Ontario School of Medicine

Evaluation of Direct Oral Challenge Clinic in a Rural Ontario Setting - Pilot Project

This study aims to evaluate the outcomes of a rural-DOC Pilot clinic which will be established in the Huntsville site of Muskoka Algonquin Healthcare. Patients from the Muskoka region who are confirmed to have a low-risk penicillin allergy are eligible for participation in the DOC clinic. Following their experience with the DOC, participation in this study will be voluntary and feedback will be requested from each participant, and local primary care providers. The feedback will be used to assess the impact of the DOC clinic on participants and the medical community over the 2 - year study. Feedback will also be collected to investigate ongoing antimicrobial use for those participants who were successfully delabeled. This will be accomplished by surveying participants at six and twelve months after their DOC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Penicillin has a well-established role in treating clinical infections in humans and animals. It was the first antibiotic to be mass produced and is still used worldwide. Modifications to the penicillin molecule have yielded derivatives with activity against a broader range of bacteria. However, one of the major limitations to use of penicillin is the incidence of allergic reactions to the drug. Penicillin allergies are reported in more than 10% of outpatients and 15% of inpatients. However, more than 30% of patients have no recollection of the symptoms of their adverse reaction to a medication and the inaccurate or inadequate documentation of adverse reactions can lead to misunderstood allergies. This study will challenge low risk participants to determine if they can safely take penicillin

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontarion
      • Huntsville, Ontarion, Canada, P1H1H7
        • Recruiting
        • Muskoka Algonquin Healthcare
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals in the Muskoka region, residing in the catchment area of Muskoka Algonquin Healthcare (Huntsville and South Muskoka site) who meet the following criteria are eligible for the study.

Inclusion Criteria:

  • Greater than 18 years of age
  • In stable health
  • Penicillin allergy that is either self-reported, reported by their primary care provider or previously documented in their electronic medical record
  • Successfully screened to ensure they are low-risk for a penicillin allergy and have a PEN-FAST score of <3

Screening Criteria:

  • Did not react to penicillin in the past 10 years
  • Was never hospitalized with a penicillin reaction
  • Have no evidence of a Severe Cutaneous Adverse Reaction (SCAR)
  • Have no evidence of a Drug-Related Eosinophilia and Systemic Symptoms (DRESS)
  • Have no history of Asthma
  • Cannot recall the nature of the penicillin reaction
  • Have a history of isolated non-allergic symptoms (eg. GI upset only)
  • Only have a family history of penicillin reaction
  • If suffer from pruritus (severe itching), with or without maculopapular rash after taking Amoxicillin
  • Have no history of IgE mediated hypersensitivity reaction or angioedema

Exclusion Criteria:

  • Pregnancy
  • Active asthma or any other illness that will increase the participants' risk
  • Do not meet the low-risk screening criteria
  • Individuals who report an immune-mediated reaction to cephalosporins
  • Currently taking Beta Blockers, ACE inhibitors, antihistamines or steroids at a dose greater than prednisone 10mg per day or equivalent
  • If study physicians deem them not to be in stable health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low risk
Low risk patients will participate in the DOC challenge
Other: Screening
Patients are screened to confirm they are low risk for a penicillin allergy
Other Names:
  • No treatment
Drug: Low dose Penicillin
Low risk participants are given a low-dose of oral penicillin followed by 60 minutes of observation
Drug: Standard dose Penicillin
Participants who have taken the low dose of oral penicillin and have had no reaction are provided a second higher dose of penicillin (250mg) and observed for 60 minutes.
Other: Remove allergy label
Participants who have no reaction after 28 days have their penicillin allergy label removed from their electronic medical record and hospital record.
No Intervention: High risk
Any participant defined as more than low risk will not receive the DOC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Can a DOC operate in a rural community
Time Frame: 1 year
Report on the number of staff available and who participate, and report on facility availability
1 year
Are adequate participants available for DOC
Time Frame: 1 year
Report on the number of participants who contact the DOC for participation
1 year
Can participants be delableled through the DOC
Time Frame: 1 year
Report on the number of participants who complete the DOC and are delabeled
1 year
Number of Reactions
Time Frame: 1 year
Report on the number and type of reaction. Report the number of participants who are not delabeled.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Ontario School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Malcolm Wilson, MD, Muskoka Algonquin Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share deidentified study data as requested

IPD Sharing Time Frame

6 months after the study closes for as long as

IPD Sharing Access Criteria

Request to PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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