NCT02543827已完成3 期
Prospective Randomized, Double-blind, Parallel-controlled Versus Placebo in a Polyvalent Sublingual Bacterial Vaccine to 3 Months and 6 Months in Women With RUTI for the Immunomodulatory Efficacy Evaluation, Safety and Clinical Impact
Inmunotek S.L.10 个研究点 分布在 2 个国家目标入组 240 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 10
- 主要终点
- Decrease in the number of RUTI exacerbations.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo group.
详细描述
Double blind parallel placebo controlled study. The subjects will receive medication during three or six months and will be followed up during another twelve months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who gave their informed consent.
- •Age between 18 and 75 years.
- •Must be able to meet the dosage regimen.
- •Subjects who had had at least 5 episodes of cystitis in the last 12 months.
- •Subjects who had not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.
- •Subjects who were free of urinary tract infections at the time of inclusion in the study.
排除标准
- •Had not given their informed consent.
- •Age was not within the established age range.
- •Could not offer cooperation and/or had severe psychiatric disorders.
- •Presented a pathologic post-micturition residue.
- •Presented moderate to severe incontinence.
- •Presented genital tumours.
- •Presented Urinary tract tumours.
- •Presented lithiasis.
- •Presented alterations in the immune system.
- •Presented complicated UTIs.
结局指标
主要结局
Decrease in the number of RUTI exacerbations.
时间窗: 1 year
Average reduction of RUTI exacerbations
次要结局
- Severity of RUTI exacerbations(1 year)
- First RUTI exacerbation(1 year)
- Medication consumption(1 year)
- Health resource consumption(1 year)
- Number of visits to the emergency service(1 year)
- Number of hospitalizations due to RUTI exacerbations(1 year)
- Changes from baseline in RUTI Assessment Test(1 year)
- Percentage of difference in immunological parameters from baseline to end of the trial(1 year)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(1 year)
研究者
研究点 (10)
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