Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy
研究概览
简要总结
Beta-lactam allergy is the most prevalent drug allergy. Drug eruption is the most common symptom whereas life-threatening anaphylaxis is rather rare. A recently published study (Journal of Allergy and Clinical Immunology, January 2011, Vol. 127, p. 218-222) described the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients, disregarding their penicillin skin test results. In the proposed study the investigators will similarly challenge beta-lactam allergic patients, both children and adults for an extended (5 days) period of time. The study will include patients with a history of a skin rash following beta-lactam administration as well as patients who cannot provide any data on their presumed allergic reaction, disregarding their penicillin skin test results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of skin rash following the administration of beta-lactam antibiotic
- •Patients with a diagnosis of penicillin allergy who have no data on the nature of the symptoms that have eventually resulted in establishing this diagnosis
排除标准
- •Patients in whom the rash appeared within 1 hour after the last dose of the drug
- •Patients who also developed other anaphylactic symptoms
- •Patients who had a life-threatening rash such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or DRESS.
- •Pregnancy
结局指标
主要结局
The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy
时间窗: 5 days
In case of the development of any adverse reactions throughout the 5-day challenge patients will notify the investigators over the phone. If assessed necessary by the investigators, patients will return to the Allergy Clinic for repeated evaluation. After completion of the 5-day challenge all patients will be contacted by the investigators and will be inquired about any adverse reactions throughout the challenge. The number of participants with adverse reactions to the challenge will be reported.
次要结局
未报告次要终点
研究者
Arnon Goldberg
Head, Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel
Meir Medical Center