Cross-reactivity and Tolerability of Ertapenem in Patients With IgE-mediated Allergy to Beta-lactams
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cross-reactivity between beta-lactams and ertapenem.
研究概览
简要总结
The purpose of this study is to assess cross-reactivity and tolerability of ertapenem in patients with IgE-mediated allergy to at least one beta-lactam molecule.
详细描述
Ertapenem is a new carbapenem, stable to dehydropeptidase which has a broad antibacterial activity. Ertapenem exhibits a bactericidal mode of action and it has a long half-life of 4.5 hours; for this reason it can be developed as a single daily dose carbapenem.
In literature, no cases of IgE-mediated allergy to ertapenem have been described until now. However, a single study put in evidence a 47% rate of cross-reactivity between imipenem-cilastatin and beta-lactams in a group of patients affected by IgE-mediated allergy to these drugs. For this reason carbapenem administration to beta-lactam allergic patients has always been considered potentially harmful. Other studies reported lower cross-reactivity rates (from 7 to 11%) between imipenem-cilastatin and beta-lactams but patients of these studies did not undergo any allergy testing in order to demonstrate the pathogenesis of the reactions.
Recent studies put in evidence that imipenem has a very low cross-reactivity rate with other beta-lactams and they have a very good tolerability among patients with IgE-mediated allergy to beta-lactams: Romano et al. found a cross-reactivity rate of 0.9% between imipenem and penicillins in 112 penicillin-allergic patients (mean age 44.56 ± 15.66 ys.); Atanasković-Marković et al. found a cross-reactivity rate of 0.8% in 124 paediatric patients (age range 3-14 ys.) between imipenem and penicillins. In both groups imipenem was well tolerated by patients with negative allergy testing.
Meropenem showed to have a good tolerability too in penicillin allergic patients: Romano et al. found a cross-reactivity rate of 0.9% between penicillins and meropenem in penicillin-allergic patients (mean age 47.83 ± 15.8); Atanasković-Marković et al. found a cross-reactivity rate of 0.8% in 109 paediatric patients (age range 3-14 ys.) between meropenem and penicillins. In both groups meropenem was well tolerated by patients with negative allergy testing.
No data regarding the cross-reactivity of ertapenem with other beta-lactams and its tolerability among patients with IgE-mediated allergy beta-lactams are available in literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgE-mediated allergy to at least one beta-lactam molecule
排除标准
- •positive allergy testing to ertapenem
- •chronic diseases
- •treatment with beta-blockers
- •pregnancy
研究组 & 干预措施
ertapenem, tolerance tests
Patients with IgE-mediated allergy to beta-lactams
干预措施: ertapenem (Drug)
结局指标
主要结局
Cross-reactivity between beta-lactams and ertapenem.
时间窗: 1 day
次要结局
- Tolerability of ertapenem in patients with IgE-mediated allergy to beta-lactams.(1 day)
