Urinary Tract Infections in Kidney Transplant Recipients (URIKIT)
2021年4月13日 更新者：Poitiers University Hospital
Urinary Tract Infections in Kidney Transplant Recipients : an Observational Cohort
The purpose of this study is to better estimate the prevalence of urinary tract infections (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR) bacteria.
KIT recipients have a higher risk of UTI over the 6 first months following the transplantation.
Urine culture was done in a city lab or at hospital.
Current data on bacteriuria and candiduria lead mostly to hospital data that are incomplete..
研究概览
详细说明
The risk of UTI after a kidney transplantation is higher than in the general population.
MDR bacteria, such as extended spectrum betalactamase (ESBL)-producing enterobacteriaceae or MDR Pseumomoas aeruginosa are emerging threats due to antibiotic selective pressure.
Epidemiological data are mostly data from hospital laboratories that do not show a complete overview of the current situation.
In addition, the different centers which participated to this study received before the beginning of the study a protocol to avoid carbapenem use.
The main objective of this study is to assess the prevalence of MDR bacteria in an adult population of KIT recipients.
Through this study, the management of UTI in KIT recipients will be improved.
Data on bacteria or yeasts responsible for UTI (identification, resistance profile), antibiotic use, patients' outcome, and graft outcome will be collected.
研究类型
观察性的
注册 (预期的)
120
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Isabelle PIRONNEAU
- 电话号码：0549443203
- 邮箱：isabelle.pironneau@chu-poitiers.fr
研究联系人备份
- 姓名：François ARRIVE
- 电话号码：0630791699
- 邮箱：francois.arrive@gmail.com
学习地点
-
-
-
Poitiers、法国、86000
- 招聘中
- CHU de Poitiers
-
接触：
- Blandine RAMMAERT, PhD
- 电话号码：0549444422
- 邮箱：blandine.rammaert.paltrie@univ-poitiers.fr
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首席研究员：
- Antoine THIERRY, PhD
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Male and female
描述
Inclusion criteria
- Age ≥ 18 year-old
- Kidney transplanted for less than 5 years
- First symptomatic episode of UTI with bacteria or yeast
- To have a health insurance
Exclusion criteria
- Asymptomatic bacteriuria or candiduria
- Protected people
- Pregnant women -> 2 bacteria in the urinalysis without external or internal urinary catheter
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of UTI due to MDR bacteria
大体时间：Day 0 to 2 years
|
Proportion of MDR bacteria compared to other bacteria found in urinalysis of symptomatic KIT patients
|
Day 0 to 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Epidemiology of UTI in KIT recipients
大体时间：Day 0 to 2 years
|
Frequency of each bacteria or yeasts responsible for UTI
|
Day 0 to 2 years
|
|
Risk factors for MDR UTI
大体时间：Day 0 to 2 years
|
Comparison of demographic and clinical characteristic of patients who develop an MDR versus a non-MDR UTI
|
Day 0 to 2 years
|
|
Carbapenem use to treat UTI
大体时间：Day 0 to 2 years
|
Proportion of patients who received carbapenem for UTI treatment
|
Day 0 to 2 years
|
|
Coherence between antibiotic protocol and treatment received to treat UTI
大体时间：Day 0 to 2 years
|
Proportion of patients who received carbapenem while responsible bacteria was susceptible to other antibiotics
|
Day 0 to 2 years
|
|
UTI relapse frequency
大体时间：Day 0 to 2 years
|
Proportion of patients with at least one relaspe of UTI with the same bacteria
|
Day 0 to 2 years
|
|
UTI recurrence frequency with a different micororganism
大体时间：Day 0 to 2 years
|
Proportion of patients with more than one UTI during the study period
|
Day 0 to 2 years
|
|
Assessment of kidney function during the observation period
大体时间：Day 0 to 2 years
|
Difference between the initial kidney function (MDRD) and the final kidney function at the end of the observation period
|
Day 0 to 2 years
|
|
Graft outcome
大体时间：Day 0 to 2 years
|
Number of patients needed a dialysis
|
Day 0 to 2 years
|
|
Patients outcome
大体时间：Day 0 to 2 years
|
Number of deaths
|
Day 0 to 2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Antoine THIERRY, PHD、Poitiers University Hospital
- 研究主任：Blandine RAMMAERT、Poitiers University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月4日
初级完成 (预期的)
2022年5月4日
研究完成 (预期的)
2024年5月4日
研究注册日期
首次提交
2017年6月23日
首先提交符合 QC 标准的
2017年7月5日
首次发布 (实际的)
2017年7月7日
研究记录更新
最后更新发布 (实际的)
2021年4月14日
上次提交的符合 QC 标准的更新
2021年4月13日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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