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Pilot study investigating the efficiency and effectiveness of a clinic that is designed to remove penicillin allergy from low-risk patients who believe they are allergic to penicillin

Evaluation of direct oral challenge clinic to assess penicillin allergies in a rural Ontario Setting: pilot project

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN79913496
Enrollment
100
Registered
2023-02-07
Start date
2023-02-15
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants currently labelled with a penicillin allergy who are screened as low risk Other

Interventions

The DOC is established within the hospital with similar screening protocols used elsewhere. The research involved in this study is to determine if this clinic is feasible for small rural centres. Usin

Sponsors

Northern Ontario Academic Medicine Association
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All participants who attend the DOC are eligible to provide feedback. To participate in the DOC there are eligibility requirements to ensure participants are at low risk of an allergic response. Whether attendees complete the DOC or not they will be asked to provide feedback and satisfaction regarding the clinic. Low risk for penicillin allergy: 1. No penicillin reaction in the past 10 years 2. Never hospitalized with a reaction to penicillin 3. No evidence of a severe cutaneous adverse reaction (SCAR) 4. No evidence of drug-related eosinophilia and systemic symptoms (DRESS) 5. No history of asthma 6. Cannot recall nature of reaction or history of isolated non-allergic symptoms (e.g., GI upset only) or pruritus only without rash or simple macular papular rash as a child with amoxicillin 7. Only a family history of reaction 8. No history of IgE-mediated hypersensitivity reaction or angioedema

Exclusion criteria

Exclusion criteria: For the data collection there are no exclusion criteria. The DOC excludes moderate and high-risk allergy participants. Additionally, any sign of a reaction within the clinic would disqualify the participant from further participation. However, the research study will request those participants' feedback.

Design outcomes

Primary

MeasureTime frame
1. The recruitment pathway for participants to the DOC, measured by identifying all areas participants are referred from, and tabulating total interest (number of participants contacting the DOC) and reasons for not participating (patient satisfaction survey), immediately following the DOC and continuous 2. Participant satisfaction regarding the DOC, measured using a participant feedback survey completed (ongoing) by each participant immediately after attending the DOC 3. Physician feedback regarding the DOC, both participating physicians and those PCP of patients who may attend the DOC, measured using a physician feedback survey at 12, 24 and 36 months after program initiation 4. Complications noted within the DOC measured using the data acquisition sheet, compiled quarterly and reported annually to the REB and at project completion 5. Collaborative experience of the clinic, the hospital and the research team for the DOC, measured using retrospective reporting and qualitative interviews at 24 and 36 months 6. Program feasibility in small rural centres, measured using the total number of participants, number of participants screened out, number of participants completing the DOC and the number of participants reporting confidence in being prescribed penicillin in the participant questionnaire at 6, and 12 months after the DOC (for each patient) 7. Template of the program for similar communities who may want to replicate the program, measured using processes completed and adapted (if required) at 36 months

Secondary

MeasureTime frame
The overall program cost/benefit for the clinic measured using cost estimation for clinic and administrative time compared to cost estimation for participants to receive skin testing at 36 months

Countries

Canada

Contacts

Public ContactLisa Allen
lisa.allen@mahc.ca+1 (0)7056622901

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026