2024-516591-15-00招募中4 期
Intravenous Fosfomycin in hospitalized patients with complicated urinary tract infections due to Third-generation cephalosporinresistant Enterobacterales
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 548
- 试验地点
- 3
- 主要终点
- Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)
研究概览
简要总结
To investigate the non-inferiority of IV fosfomycin compared to the best available therapy according to current clinical practice/choice
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •cUTI, in adult patients, defined as the presence of signs or symptoms, pyuria, and growth of cephalosporin-non-susceptible, fosfomycin susceptible Enterobacterales in urine (a positive urine culture of 105 colony-forming units (CFU)/ml).
排除标准
- •Hemodynamical instability in the last 24 hours - Alternative source of infection explaining the fever according to physician’s judgement - Prostatitis, orchitis, or epididymitis - Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy prior to EOT) - pregnancy and/or breastfeeding
结局指标
主要结局
Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)
Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)
次要结局
- Clinical cure rates in the 2 treatment groups in MITT, m-MITT, clinical evaluable, and microbiologic evaluable populations at TOC;clinical evaluation after 48 h from first drug administration;microbiological eradication rates in m-MITT and ME populations at TOC;Mortality for any reason until day 30;Hospital readmissions or extended hospitalization; Number of hospital re-admissions until day 90;Relapse or reinfections;Clostridioides difficile associated diarrhea;AE related to fosfomycin treatment
研究者
Marianna Meschiari
Scientific
Azienda Ospedaliero Universitaria Di Modena
研究点 (3)
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