Evaluation of a Direct Oral Penicillin Challenge in a Rural Community

NCT06192277 | Unknown

• 1 other identifier: DOC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergy Penicillin

Outcome Measures

Primary Outcomes (4)

• Can a DOC operate in a rural community

  Report on the number of staff available and who participate, and report on facility availability

  1 year

• Are adequate participants available for DOC

  Report on the number of participants who contact the DOC for participation

  1 year

• Can participants be delableled through the DOC

  Report on the number of participants who complete the DOC and are delabeled

  1 year

• Number of Reactions

  Report on the number and type of reaction. Report the number of participants who are not delabeled.

  1 year

Study Arms (2)

Low risk

EXPERIMENTAL

Low risk patients will participate in the DOC challenge

Other: Screening; Drug: Low dose Penicillin; Drug: Standard dose Penicillin; Other: Remove allergy label

High risk

NO INTERVENTION

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

Interventions

Screening OTHER

Patients are screened to confirm they are low risk for a penicillin allergy

Also known as: No treatment

Low risk

Low dose Penicillin DRUG

Low risk participants are given a low-dose of oral penicillin followed by 60 minutes of observation

Low risk

Standard dose Penicillin DRUG

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.

Low risk

Remove allergy label OTHER

Participants who have no reaction after 28 days have their penicillin allergy label removed from their electronic medical record and hospital record.

Low risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Ontario School of Medicine: lead

Study Sites (1)

Muskoka Algonquin Healthcare

Huntsville, Ontarion, P1H1H7, Canada

RECRUITING

MeSH Terms

Interventions

Mass Screening; Penicillins

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Malcolm Wilson, MD

  Muskoka Algonquin Healthcare

  STUDY DIRECTOR

Central Study Contacts

Maggie Partya-Sitnik, BA

CONTACT

705-789-0022; magdalena.sitnik@mahc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator, Director of Reserach, Parry Sound, Huntsville and Bracebridge

Model Details: Participants are initially screened to confirm they are at a low risk of reacting to a direct oral penicillin challenge. Low-risk participants are provided oral penicillin and observed for a reaction. If no reaction occurs, (immediate or delayed up to 28 days) patients have their penicillin allergy removed from their electronic medical record with their primary care provider and the local hospital.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 5, 2024
• Study Start: October 6, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 15, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after the study closes for as long as
• Access Criteria: Request to PI

Locations

CA (1)