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临床试验/NCT06392282
NCT06392282进行中(未招募)不适用

MV-140 Efficacy in Recurrent Urinary Tract Infections

Unidade Local de Saúde Santa Maria0 个研究点目标入组 104 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
104
主要终点
UTI episodes

研究概览

简要总结

We will access the efficacy of MV-140 immunotherapy in the prevention of recurrent urinary tract infections in a cohort of Portuguese patients.

详细描述

Urinary tract infections represent a highly frequent and debilitating disease, responsible for an extensive use of antibiotics for treatment and prophylaxis. Non-antibiotic therapies, such as oral vaccines, have been developed, in order to avoid antibiotic use. MV-140 is a sublingual vaccine comprised of 4 inactivated bacteria - E. coli, K. pneumoniae, E. faecalis and Proteus vulgaris. It is approved for the prevention of recurrent UTIs, with promising results in the few published results to date. The efficacy of this tool in the Portuguese population is, however, still unknown. Since the prevalence of pathogens responsible for infections and overall antibiotic use are highly variable worldwide, the results of studies conducted so far are not directly applicable in other regions. Therefore, we designed the present study which aims at assessing the efficacy of immunotherapy with MV-140 In the Portuguese population. It is a prospective observational study, in which patients will be asked to report their condition before and 1 year after therapy.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • At least 3 positive urine culture UTIs in the preceding 12 months
  • Ability to understand and fill the informed consent

排除标准

  • I. History of genitourinary tumours II. Urinary lithiasis III. Immunodeficiency IV. Pregnancy V. Simultaneous use of any other urinary tract prevention vaccines or prophylactic antibiotics

结局指标

主要结局

UTI episodes

时间窗: 1 year

Change in number of UTI episodes

次要结局

未报告次要终点

研究者

发起方
Unidade Local de Saúde Santa Maria
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Filipe Abadesso Lopes

Principal Investigator

Unidade Local de Saúde Santa Maria

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