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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low risk | Experimental | Low risk patients will participate in the DOC challenge |
|
| High risk | No Intervention | Any participant defined as more than low risk will not receive the DOC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening | Other | Patients are screened to confirm they are low risk for a penicillin allergy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Inclusion Criteria:
Screening Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maggie Partya-Sitnik, BA | Contact | 705-789-0022 | magdalena.sitnik@mahc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Malcolm Wilson, MD | Muskoka Algonquin Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muskoka Algonquin Healthcare | Recruiting | Huntsville | Ontarion | P1H1H7 | Canada |
We will share deidentified study data as requested
6 months after the study closes for as long as
Request to PI
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| D010406 | Penicillins |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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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.
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| Low dose Penicillin | Drug | Low risk participants are given a low-dose of oral penicillin followed by 60 minutes of observation |
|
| 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. |
|
| 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. |
|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |