NCT03922919Unknown4 期
Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Frequency of occurrence of digestive carrying of EB C3G-R
研究概览
简要总结
The aim of this study was to compare the frequency of occurrence of digestive carrying of 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), acquired during hospitalization in one of the participating departments, between patients treated with ceftriaxone and patients treated with cefotaxime
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age ≥ 18 years old
- •Indication for antibiotic treatment with a 3rd generation injectable cephalosporin (cefotaxime or ceftriaxone)
- •Signed Informed Consent
排除标准
- •Hypersensitivity to ceftriaxone or cefotaxime, to another cephalosporin or to any of the excipients of the specialities concerned.
- •History of severe hypersensitivity (e.g., anaphylactic reaction) to another class of antibacterial agent of the beta-lactam family (penicillins, monobactams and carbapenes)
- •Subcutaneous administration of ceftriaxone
- •Pregnant and breastfeeding woman
- •Suspicion of Pseudomonas infection or documented Pseudomonas infection requiring ceftazidime treatment
- •Suspicion of group III enterobacteriaceae infection or group III enterobacteriaceae infection requiring cefepime treatment
研究组 & 干预措施
Cefotaxime or ceftriaxone group
Active Comparator
free use of cefotaxime or ceftriaxone by the investigator
干预措施: Rectal swab (Procedure)
Cefotaxime or ceftriaxone group
Active Comparator
free use of cefotaxime or ceftriaxone by the investigator
干预措施: Cefotaxime/ceftriaxone (Drug)
Cefotaxim group
Experimental
Systematic use of cefotaxime
干预措施: Cefotaxime Injection (Drug)
Cefotaxim group
Experimental
Systematic use of cefotaxime
干预措施: Rectal swab (Procedure)
结局指标
主要结局
Frequency of occurrence of digestive carrying of EB C3G-R
时间窗: 30 days after inclusion
Frequency of occurrence of digestive carrying of EB C3G-R
次要结局
- incidence rate of EB C3G-R infections(2 years)
- number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R)(30 days after inclusion)
研究者
研究点 (1)
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