Evaluation of Direct Oral Challenge Clinic in a Rural Ontario Setting - Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Can a DOC operate in a rural community
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low risk
Low risk patients will participate in the DOC challenge
干预措施: Screening (Other)
Low risk
Low risk patients will participate in the DOC challenge
干预措施: Low dose Penicillin (Drug)
Low risk
Low risk patients will participate in the DOC challenge
干预措施: Standard dose Penicillin (Drug)
Low risk
Low risk patients will participate in the DOC challenge
干预措施: Remove allergy label (Other)
结局指标
主要结局
Can a DOC operate in a rural community
时间窗: 1 year
Report on the number of staff available and who participate, and report on facility availability
Are adequate participants available for DOC
时间窗: 1 year
Report on the number of participants who contact the DOC for participation
Can participants be delableled through the DOC
时间窗: 1 year
Report on the number of participants who complete the DOC and are delabeled
Number of Reactions
时间窗: 1 year
Report on the number and type of reaction. Report the number of participants who are not delabeled.
次要结局
未报告次要终点
研究者
Lisa Allen
Research Coordinator, Director of Reserach, Parry Sound, Huntsville and Bracebridge
Northern Ontario School of Medicine