跳至主要内容
临床试验/NCT03350425
NCT03350425已完成不适用

Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

University of Cologne12 个研究点 分布在 1 个国家目标入组 792 人开始时间: 2017年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
792
试验地点
12
主要终点
Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago

研究概览

简要总结

The investigators compare two strata of vaccinated patients: those recently vaccinated and those vaccinated more than two years ago. The primary objective is to compare pneumonia rates between the groups. As exploratory objectives, the investigators will describe the anti-pneumococcal antibody titers in hemodialysis patients as a function of time since vaccination, and determine factors influencing antibody kinetics. Further exploratory objectives investigate the relationship between antibody titers and the incidence of pneumonia in hemodialysis patients and extrapolate a possible cut-off for protection from pneumonia.

详细描述

Participating sites will screen all hemodialysis patients at their outpatient dialysis clinic for eligibility. Eligible patients will be approached and informed by their treating physician. If a patient agrees to participate in the study and to sign an informed consent form, basic data regarding vaccination history, underlying disease, etc. will be entered or electronically imported into the study eCRF. Pneumococcal antibody titers will be drawn at baseline and every 3 months. For newly vaccinated patients baseline titers will be drawn 4 weeks after the vaccination. DZIF CTUs will coordinate titer assessment schedules and inform the participating physicians of upcoming blood samplings. The samples will be taken on dialysis days and thus constitute only a minimal additional burden for both patients and physicians. DZIF CTUs will actively follow up on study patients for 2 years after enrolment. This follow-up will include validation of all hospitalizations and deaths documented in an electronic registry database to assess whether the primary endpoint (pneumonia) occurred. Additionally, dialysis units will be contacted every 6 months to assess if pneumonia occurred, which did not require hospitalization. DZIF CTUs will document titer assessment results in the eCRF. Titers will not be disclosed to the attending physicians because revaccination due to knowledge of titers would produce bias. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (e.g. RKI STIKO recommendations).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Signed informed consent form including enrolment in registry database (QiN-registry)
  • Patients with stage 5 chronic kidney disease treated with chronic hemodialysis
  • Patients who are either already vaccinated or eligible and willing to be vaccinated against pneumococcal infection in accordance with current STIKO recommendations
  • Age of 18 years or older

排除标准

  • Patients unwilling/ineligible for vaccination under current STIKO recommendations

结局指标

主要结局

Comparison of pneumonia rates between newly vaccinated hemodialysis patients and those vaccinated against pneumococcal infection more than 2 years ago

时间窗: 2 years

次要结局

  • Factors influencing antibody kinetics(2 years)
  • Pneumococcal antibody kinetics as a function of time since vaccination.(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oliver Cornely, MD

Prof. Dr.

University of Cologne

研究点 (12)

Loading locations...

相似试验