Oral Penicillin Challenge and Allergy De-labeling in the Phoenix Children's Hospital Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- True Penicillin Allergies
研究概览
简要总结
The primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. The secondary purpose is to evaluate the safety and feasibility of administering oral penicillin allergy challenges in the Pediatric Emergency Department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies)
- •Patients at low risk of anaphylaxis as determined by the study questionnaire
- •Patients who would normally be prescribed amoxicillin, amoxicillin-clavulanate or another penicillin for their current bacterial infection, including otitis media, Group A Streptococcal pharyngitis, pneumonia. sinusitis, dog and cat bite wounds, regimens for Helicobacter pylori eradication, or other acute infections deemed susceptible.
- •Patients who are interested in participating
- •Patients who have an acceptable surrogate to give consent on the subject's behalf
- •Patients whose surrogate (parent/caregiver) speaks English or Spanish
排除标准
- •Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate
- •Patients who have multiple drug allergies
研究组 & 干预措施
Oral Challenge
Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge.
干预措施: Amoxicillin 500mg (Drug)
结局指标
主要结局
True Penicillin Allergies
时间窗: 24 hours after amoxicillin oral challenge
Percentage of study patients presenting to the pediatric ED who received the amoxicillin oral challenge who demonstrated a true IgE-mediated allergic reaction
次要结局
- Amoxicillin Oral Challenge Safety - High-Risk Reactions(24 hours after amoxicillin oral challenge)
- Amoxicillin Oral Challenge Safety - Admissions(24 hours after amoxicillin oral challenge)
- Amoxicillin Oral Challenge Safety - Re-admissions(24 hours after amoxicillin oral challenge)
- Amoxicillin Oral Challenge Safety - Deaths(24 hours after amoxicillin oral challenge)
- Amoxicillin Oral Challenge Feasibility(24 hours after amoxicillin oral challenge)
研究者
Diane E. Hindman, MD
Attending Physician
Phoenix Children's Hospital