EUCTR2021-002911-72-ES进行中（未招募）1 期
A randomized, double blind, double dummy, parallel group, multicenter clinical trial to evaluate the safety and clinical and microbiologic efficacy of oral fosfomycin calcium in adult women with uUTI.
aboratorios ERN, S.A.0 个研究点目标入组 384 人开始时间: 2021年12月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 384
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Adult women (=18 years) with initial uncomplicated urinary tract infection (uUTI).
- •Must have = two of the following signs of uUTI:
- •oUrinary frecuency
- •oUrinary urgency
- •oDysuria (pain of burning on urination)
- •oSuprapubic pain
- •Mid-stream urine specimen with dipstick analysis positive for both:
- •oLeukocyte esterase (evidence of pyuria)
- •Using effective barrier contraception (there will be a pregnancy test by determining urine ß-HCG levels in Visit 0)
- •Subject able to communicate effectively and provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Clinical evidence of renal pathology (fever and renal first percussion positive…).
- •Patients with galactose intolerance, with glucose-galactose malabsorption or with insufficiency of sucrase isomaltase
- •Women with gynaecological infections and cUTI.
- •Pregnant or nursing woman.
- •Taking part in another clinical trial during the two months prior to the current trial.
研究者
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