MV-140 Efficacy in Recurrent Urinary Tract Infections
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
- 否
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
Filipe Abadesso Lopes
Principal Investigator
Unidade Local de Saúde Santa Maria
