Inpatient Penicillin Allergy Delabeling Pilot Project at University Hospitals-Rainbow Babies and Children's Hospital in Cleveland, Ohio
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Confirmed Allergy Status
研究概览
简要总结
The study will identify pediatric patients 3-18 years old who have penicillin allergy label in the electronic medical record. Those who are identified will be stratified into no-risk, low-risk and high-risk category using a screening questionnaire. The following definitions will be followed:
No-risk: Patients who are historically labeled with penicillin allergy in the EMR based on family history alone OR those who have tolerated penicillin after a concerning incident without any reaction OR with penicillin allergy label but deny any history of reaction to any form of penicillin on screening questionnaire
Low-risk: Patients with previous reaction not suggestive of anaphylaxis (defined below) AND not requiring hospitalization for the reaction OR reaction considered non- immunologic (e.g. diarrhea, nausea, yeast vaginitis) OR exposure to penicillin- containing antibiotic after the date of reported reaction with no anaphylaxis and hospitalization AND no serious types of delayed reactions such as Steven- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute interstitial nephritis (AIN), drug-induced hepatitis or other documented organ injury, drug rash eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia, and serum sickness. Patients who had delayed reaction (onset more than 24 hours) of isolated, non-progressive symptoms (such as rash/hives alone) also belong to this group.
High-risk: Patients with penicillin allergy label on EMR with previous reaction suggestive of anaphylaxis (defined below) OR requiring hospitalization/epinephrine administration for the reaction OR reactions considered immunologic (angioedema, joint pains) OR involving serious types of reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute interstitial nephritis (AIN), drug-induced hepatitis or other documented organ injury, drug rash eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia, and serum sickness. Patients who were previously diagnosed with penicillin allergy by an allergist also belong to the high-risk group.
Patients in the no-risk group will be immediately delabeled. Patients in the high-risk group will be referred to allergy/immunology for further work up. The focus of this study is to identify the patients who belong to the low-risk group. This group of patients will be subjected to graded oral amoxicillin challenge testing. Those who will have reactions compatible with allergy will have their allergy status retained in the electronic medical record. Those that will not have reactions or those that will have reactions that are not compatible with allergy will be delabeled in the electronic medical record.
详细描述
A. Specific Aims and Hypotheses
General Objective:
To verify pediatric patients with reported penicillin allergy in electronic medical record (EMR) by performing direct oral amoxicillin challenge testing.
Hypothesis: Pediatric patients with reported penicillin allergy in EMR can be verified by performing direct oral amoxicillin challenge testing.
Specific objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for screening
- •Patients 3-18 years old admitted at our institution with penicillin allergy label in electronic medical record
- •Patients with available parent/s or legal guardian who can give both written and verbal consent to the oral challenge testing
- •Patients with available parent/s or legal guardian during the conduct of oral amoxicillin challenge testing
- •Inclusion Criteria for oral challenge test
- •Patients who will be identified as low-risk patients based on the standardized screening questionnaire. Low-risk group patients are those patients with previous reaction not suggestive of anaphylaxis AND not requiring hospitalization for the reaction OR reaction considered non-immunologic (e.g. diarrhea, nausea, yeast vaginitis) OR exposure to penicillin-containing antibiotic after the date of reported reaction with no anaphylaxis and hospitalization AND no serious types of delayed reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute interstitial nephritis (AIN), drug-induced hepatitis or other documented organ injury, drug rash eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia, and serum sickness. - ---- Patients who had delayed reaction (onset more than 24 hours) of isolated, non-progressive symptoms (such as rash/hives alone) also belong to this group.
排除标准
- •Exclusion Criteria for screening
- •Patients who cannot tolerate amoxicillin/penicillin by enteral route.
- •Patients with no parents or legal guardian available to give both written and verbal consent to the oral challenge testing
- •Patients with no available parents or legal guardian during the conduct of oral amoxicillin challenge testing
- •Patients currently on antihistamine or have received antihistamine in the previous 48 hours
- •Patients who are critically ill
- •Patients who have been vomiting more than twice in the past 24 hours or are actively vomiting
- •Patients with respiratory symptoms warranting oxygen therapy or pulmonary finding of wheezing or stridor
- •Patients identified as having anaphylactic reaction to penicillin in the electronic medical record
- •Exclusion Criteria for oral challenge testing
- •Patients who will be identified as no-risk patients based on the standardized screening questionnaire. No-risk group patients are those patients who are historically labeled with penicillin allergy in the EMR based on family history alone OR those who have tolerated penicillin after a concerning incident without any reaction OR with penicillin allergy label but deny any history of reaction to any form of penicillin on screening questionnaire
- •Patients who will be identified as high-risk patients based on the standardized screening questionnaire. High-risk group patients are those patients with penicillin allergy label on EMR with previous reaction suggestive of anaphylaxis OR requiring hospitalization/epinephrine administration for the reaction OR reactions considered immunologic (angioedema, joint pains) OR involving serious types of reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute interstitial nephritis (AIN), drug-induced hepatitis or other documented organ injury, drug rash eosinophilia systemic symptoms (DRESS), hemolytic anemia, drug-induced cytopenia, and serum sickness. Patients who were previously diagnosed with penicillin allergy by an allergist also belong to the high-risk group.
研究组 & 干预措施
Low Risk Patients
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
干预措施: Graded Oral Amoxicillin Challenge (Drug)
Low Risk Patients
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
干预措施: De-labelling in electronic medical record (Other)
Low Risk Patients
This is the group of patients who will undergo the graded oral amoxicillin challenge testing. Total dose of the amoxicillin will be 45 mg/kg (maximum of 1000 mg). 10 % of this dose will be given first followed by 90 % of the dose 30 minutes after. Each dose will be given only once.
干预措施: Referral to Allergy Immunology/Retention of Allergy Label (Other)
No Risk Patients
Patients in the group will be de-labeled in the electronic medical record for No Risk for allergic reaction to amoxicillin based on screening questionnaire.
干预措施: De-labelling in electronic medical record (Other)
High Risk
Patients in this group are deemed high risk for allergic reaction to penicillin based on screening questionnaire and will remain labeled with allergy in the electronic medical record. They will be referred as outpatient to allergy-immunology for further evaluation.
干预措施: Referral to Allergy Immunology/Retention of Allergy Label (Other)
结局指标
主要结局
Number of Participants With Confirmed Allergy Status
时间窗: 3 hours
Participants with penicillin allergy status verification based on questionnaire and challenge
次要结局
- Number of Participants Categorized as Low Risk for Penicillin Allergy Reaction With Confirmed True Penicillin Allergy as Measured by Failed Oral Amoxicillin Challenge(3 hours)
- Number of Participants With Confirmed True Allergy Without Challenge(3 hours)
- Number of Participants With no Penicillin Allergy Confirmed and De-labelled of Penicillin Allergy Based on Results of Questionnaire.(3 hours)
研究者
Ankita Desai
Associate Professor, Director of Pediatric Antimicrobial Stewardship
University Hospitals Cleveland Medical Center