Protocol 19-01: Canadian, Single Centre, Pilot, Open Label Study to Evaluate the Efficacy and Safety of the Bacterial Vaccine Uromune in Treating Recurrent Urinary Tract Infections in Women.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Complete Responder
研究概览
简要总结
To determine the effectiveness and safety of the vaccine Uromune in Canadian women with recurrent urinary tract infection.
详细描述
The proposal is for a real life clinical practice study in which female participants with a predefined history of recurrent UTIs in the previous year will be treated with 3 months of oral vaccine with a further 9 months of follow-up. The primary outcome will be no UTI in the 9 month efficacy period following completion of the vaccine (definition of a responder). A clinically significant and important outcome will be defined as a responder rate of 50% (50% of participants who had at least 3 UTIs in the previous year reporting no UTIs after therapy initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Can provide written consent and willingness to comply with all aspects of study treatment and study requirements.
- •Individuals who have had at least 3 episodes of a UTI in the past 12 months or 2 UTI episodes in the past 6 months. At least one of the UTI episodes must be associated with a positive urine culture with a traditional uropathogen including Escherichia coli, Proteus spp. Staphyloccous sp. Enterococcus sp. Klebsiella sp. or Pseudomonas aeruginosa.
- •Post-menopausal for a minimum of 1 year or negative pregnancy test if participant is of child bearing potential and agreement to acceptable contraceptive use from Screening Visit 1 to final follow up visit if participant is sexually active. Medically acceptable methods of contraception include hormonal contraception (i.e. estrogen, and/or progesterone or preparations that contain a combination of these hormones), non-hormonal intrauterine device or double barrier method (i.e. condom with foam or vaginal spermicidal suppository, or diaphragm with spermicide) or vasectomy of sole sexual partner. Complete abstinence alone can be used as a method of contraception.
- •Free of a urinary tract infection at the time of trial inclusion.
排除标准
- •History of bladder tumours including uterine, cervical, vaginal or urethral cancer.
- •Worrisome post-voiding residual (investigator's discretion).
- •Infection related to urinary lithiasis.
- •Any immunological disease requiring active therapy.
- •Currently receiving Immunotherapy.
- •Taking any prophylactic antibiotics at screening. Any prophylactic antibiotics must be stopped the day of the screening visit.
- •Any known intolerance to the ingredients of the Uromune® Immunotherapy.
- •Have any other condition or disease which, in the opinion of the investigator, could compromise participant safety or interfere with the participant's participation in the study or in the evaluation of the study results.
结局指标
主要结局
Complete Responder
时间窗: 12 months
Participant considered complete responder if no UTI requiring antibiotics reported in the 9 month efficacy period following completion of 3 month vaccine therapy.
次要结局
- Number of UTI in the Efficacy Period(12 months)
研究者
Dr. J. Curtis Nickel
Professor or Urology
Queen's University