Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- randomization rate
研究概览
简要总结
Urinary tract infections (UTI) represent one of the most common morbidities in individuals with spinal cord injury (SCI) and reason for re-hospitalization. The consequences of recurrent UTI are a decrease in quality of life and considerable health costs. Immunomodulation therapy with UroVaxom is a very promising method for the prevention of UTI, however data in individuals with SCI are very limited. The primary objective of this pilot study is to evaluate the feasibility (recruitment rate, patient attrition, compliance, assessment procedures etc.) of a main trial. A secondary objective is to collect data for an informed sample size calculation. Furthermore, the clinical and biological changes after immunomodulation therapy will be investigated.
This is a randomized, placebo-controlled, mono-centric pilot study investigating the feasibility of a main trial regarding the effectiveness of immunomodulation with UroVaxom in the prevention of UTI and the effect on the immune system in individuals with acute SCI during primary rehabilitation. There will be two parallel groups of 12 participants each. Group allocation will be based on a block-randomization stratified according to sex. Study participants and outcome assessors will be blinded to the group allocation. The nursing staff will be unblinded and will administer the treatment and the placebo. Study participants will either receive Uro-Vaxom (one tablet / day) or an off-the-shelf placebo for 90 days. After termination of the treatment, the study participants will be followed for 12 months. Blood and urine samples will be taken before and 90 days, 6 months and 12 months after treatment start.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute SCI (within 8 weeks after SCI)
- •onset of SCI within 72h
- •age from 18 to 70 years
- •informed consent as documented by signature
排除标准
- •known hypersensitivity to investigational product,
- •other immunomodulation therapy,
- •immunosuppressant therapy,
- •oncological condition or therapy,
- •autoimmune diseases, nephropathy, bladder stones,
- •women who are pregnant (pregnancy test) or breast feeding,
- •participation in another study with an investigational drug within the 30 days preceding and during the present study
研究组 & 干预措施
Immunomodulation
Lyophilized lysate of 18 E. coli strains (6 mg) for oral application. A treatment lasts 90 days (one capsule daily).
干预措施: Uro-Vaxom (Drug)
Placebo
Oral placebo tablet once daily for 90 days.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
randomization rate
时间窗: at study completion, an average of 2 years
proportion of eligible patients who were enrolled
次要结局
- positive screening rate(at study completion, an average of 2 years)
- retention rate(at study completion, an average of 2 years)
- urine culture result(during follow-up of 12 months)
- change in urinary immunoglobulin A levels(time 0 and 12 months)
- count of urinary tract infection(during follow-up of 12 months)
- drop-out rate(at study completion, an average of 2 years)