Efficacy of Intravenous Fosfomycin in the Treatment of Complicated Urinary in Real-life Conditions. Impact of the CMI and Baseline Mutations. FOSFO-MIC Project
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The proportion of development of resistance (or decrease in sensitivity) to fosfomycin during or after treatment: Presence of mutation in genes uhpT, uhpA, uhpB, uhpC, uhpT, crp, cyaA, ptsl and fosA and measure CMI.
研究概览
简要总结
This will be a prospective observational multicentre study in real-life conditions of patients with complicated urinary infection of community presentation caused by Escherichia coli using intravenous fosfomycin, quinolones or beta-lactams.
It's a multicenter and multinational study and it will include 200 patients in the fosfomycin cohort and 200 patients in the control cohort (quinolones or beta-lactams).
详细描述
The objectives are:
- To asses the clinical and microbiological efficacy and safety of intravenous fosfomycin in the treatment of complicated urinary tract infections due to Escherichia coli in real life conditions, in comparison with a matched cohort of patients treated with quinolones or beta-lactams.
- To evaluate the frequency of microbiological failure and development of resistance (or decrease in sensitivity) in Escherichia coli isolates, depending on different pharmacokinetic and pharmacodynamic parameters, with special emphasis on fAUC0-24/MIC.
- To evaluate the frequency of microbiological failure and development of resistance (or decrease in sensitivity) and their association with the existence of basal mutations in genes related to intracellular transport or regulation of these transporters.
For objective 1, a study of prospective mated cohorts (fosfomycin cohort versus quinolones or beta-lactams cohort) will be performed, and for objectives 2 and 3 a prospective cohort study (fosfomycin cohort) will be conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The proportion of development of resistance (or decrease in sensitivity) to fosfomycin during or after treatment: Presence of mutation in genes uhpT, uhpA, uhpB, uhpC, uhpT, crp, cyaA, ptsl and fosA and measure CMI.
时间窗: 30 days
The proportion of development of resistance (or decrease in sensitivity) to fosfomycin during or after treatment: Presence of mutation in genes uhpT, uhpA, uhpB, uhpC, uhpT, crp, cyaA, ptsl and fosA and measure CMI.
The proportion of microbiological failure on the test of cure in the fosfomycin cohort (measured as isolation of Escherichia coli in uroculture on the test of cure).
时间窗: 21 days
The proportion of microbiological failure on the test of cure in the fosfomycin cohort (measured as isolation of Escherichia coli in uroculture on the test of cure).
The difference in the proportion of subjects getting clinical-microbiological cure on the test of cure between the fosfomycin cohort and the quinolones or beta-lactams cohort
时间窗: 21 days
The difference in the proportion of subjects getting clinical-microbiological cure (disappearance of all new symptoms or signs related to urinary infection and negative uroculture) on the test of cure between the fosfomycin cohort and the quinolones or beta-lactams cohort
次要结局
- The difference in the proportion of solicited EAs in subjects in fosfomycin cohort and quinolones or beta-lactams cohort.(Day 5 through Day 21)
- To evaluate the frequency of microbiological failure and development of resistance (or decrease in sensitivity) in Escherichia coli isolates.(30 days)