A Randomized, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Number of symptomatic UTIs
研究概览
简要总结
Symptomatic urinary tract infections (UTIs) are one of the main causes of morbidity and the main cause of re-hospitalization in subjects with neurogenic bladder. Long-term antibiotic therapy increases the risk of multi-resistant bacterial infections, without reducing the rate of symptomatic UTIs. Our non-comparative preliminary study has shown that Weekly Oral Cyclic Antibiotic Programme (single, weekly dose of antibiotic X on even weeks, and antibiotic Y on odd weeks) seem to drastically reduce both the number of symptomatic UTIs and the number of hospitalizations in patients with neurogenic bladder, without affecting bacterial ecology.
The objective of this study is to validate this preliminary work with a large-scale randomized, parallel-group, multicenter study.
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
- None
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
- •subject over 18 years of age
- •having a neurogenic bladder with automatic catheter and pharmacologic disconnection of the detrusor muscle
- •having at least 4 symptomatic UTIs per year with bacterial sensitivity to the chosen antibiotics
- •having given full consent to participate in the study
- •being the recipient of social security benefits
排除标准
- •known allergy or hypersensitivity to useful antibiotics (to which the bacterium or bacteria are sensitive) or to one of their components
- •other contraindication in the administering of useful antibiotics
- •urinary volume flow >500 ml during automatic catheter
- •different urinary drainage method than automatic catheter
- •occurrence of stones in the urinary tract
- •infection due to endo urinary material (urinary prosthesis, ureteral stent)
- •creatinine clearance <60 ml/min
- •patient under guardianship
- •women who are pregnant, nursing, or who may become pregnant
研究组 & 干预措施
Weekly Oral Cyclic Antibiotic programme
干预措施: Weekly Oral Cyclic Antibiotic programme (Drug)
结局指标
主要结局
Number of symptomatic UTIs
时间窗: During the 6-month follow-up
Symptomatic UTIs are defined by the presence of infection or reinfection by the same bacteria, in combination with the presence of definite clinical signs of infection (autonomous hyper-reflexivity, spasticity, leakage, contractures, pyuria, fever, shivers).
次要结局
- The number of feverish UTIs(During the 6-month follow-up)
- The emergence of multi-resistant bacteria in urine (cultures), digestive bacteria (anal swabs), oro-pharynx bacteria (nasal swabs), and semi-quantitative research of multi-resistant bacteria in the stool.(During the 6-month follow-up)
- The duration of UTI-related hospitalizations(During the 6-month follow-up)
- The global antibiotic consumption.(During the 6-month follow-up)
- The number of urine culture negative(During the 6-month follow-up)
- the quality of life(During the 6-month follow-up)
- The number of hospitalizations(During the 6-month follow-up.)
- The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics(During the 6-month follow-up.)