跳至主要内容
临床试验/NCT03179384
NCT03179384已完成4 期

Impact on the Intestinal Microbiota of Treatment With Ceftriaxone in Women's Acute Community Pyelonephritis

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年6月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
9
试验地点
1
主要终点
Emergence of ceftriaxone-resistant Enterobacteriaceae

研究概览

简要总结

Acute pyelonephritis (APN) corresponds to infections of the renal parenchyma. The annual incidence of these infections is estimated at 4-6 million cases in France, with 60 to 90% of patients managed in general city medicine. The ceftriaxone, parenteral third-generation cephalosporin (C3G), occupies an important place in the antibiotic treatment of these infections: this is the recommended probabilistic treatment, and in some situations the treatment can be continued in its entirety via a Ceftriaxone monotherapy.

The aim of the last antibiotic plan is to avoid the use of antibiotic therapies with a high selection capacity (cephalosporins, penicillins, fluoroquinolones, etc.) and thus reduce the incidence and prolongation over time of the digestive carriage of multi-resistant bacteria .

To date, there have been few studies evaluating the impact of ceftriaxone on the emergence of multi-resistant bacteria on an individual scale, with rather heterogeneous results (13-86% C3G resistance).

Thus, before considering randomized studies comparing the ecological impact of different molecules or therapeutic regimens in the treatment of ANP, it is necessary to have a precise and rigorous evaluation of the ecological impact of the molecule reference in this indication.

The investigators propose a study to evaluate the impact on the digestive flora at 1 month of a ceftriaxone antibiotic therapy (7 days) in the management of acute pyelonephritis in women.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Over 18 years old
  • Admitted to the emergency department with a diagnosis of PNA (simple or at risk of complications, without signs of seriousness)

排除标准

  • Hypersensitivity to ceftriaxone, to another cephalosporin or to any of the excipients
  • A history of severe hypersensitivity (eg anaphylactic reaction) to another class of antibacterial agent in the beta-lactam family (penicillins, monobatams and carbapenems)
  • Severe pyelonephritis, including obstructive APN
  • Pyelonephritis in patients with a urinary catheter
  • Antibiotic treatment in the previous 6 months
  • Chronic dialysis patient
  • Patient with hepatic impairment
  • Pregnancy or breast-feeding in progress

研究组 & 干预措施

ceftriaxone treatment

Experimental

干预措施: Ceftriaxone (Drug)

结局指标

主要结局

Emergence of ceftriaxone-resistant Enterobacteriaceae

时间窗: at 28 days

The emergence of ceftriaxone-resistant Enterobacteriaceae at 28 days after cessation of treatment on rectal swab.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Impact on the Intestinal Microbiota of Treatment... | 临床试验