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临床试验/NCT04791098
NCT04791098Unknown不适用

Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年9月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Vaccination coverage

研究概览

简要总结

Solid-organ transplant patients are at increased risk of infectious diseases. Among this population, infectious diseases may be life-threatening or lead to graft rejection. Their prevention is an important challenge. Despite specific national recommendations, vaccination is underutilized. That is why we propose a dedicated infectious diseases consultation during pre-kidney transplantation assessment.

详细描述

The main objective of this study is to impove vaccine coverage before kidney transplantation.

Enrollment was based on the waiting list for a kidney transplant. Patients newly listed are invited to participate by the transplant team (nephrology department) ; for those that are already registered, a notification letter is sent to their home.

All patients included must :

  • complete a health questionnaire
  • take a blood test at day 0 : viral, bacterial and parasitic serologies, QuantiFERON-TB
  • take a chest X-ray and dental panoramic Patients randomized in interventional group will be seen in specific infectious diseases consultation at Clermont Ferrand Hospital. A letter of recommendations is sent to nephrologist for patients randomized in group control.

The primary study endpoint (immunization coverage) is evaluated at 6 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
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

入选标准

  • Patient over 18
  • On the waiting list for kidney transplantation at Clermont-Ferrand
  • Free and informed consent
  • Affiliation to a social security system

排除标准

  • Patient under 18
  • Protected adults (individuals under guardianship by court order
  • Pregnant and nursing women
  • Prior graft (solid organs or hematopoietic stem cells)
  • Absence of consent

结局指标

主要结局

Vaccination coverage

时间窗: Month 6

The percentage of fully immunized patients according to the Recommendations of High Council for public Health

次要结局

  • Mortality(Month 6)
  • Infectious complications(within the 6 months of the transplantation)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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