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临床试验/NCT01053377
NCT01053377Unknown4 期

A Randomised Controlled Trial on the Effect of Post-exposure Oseltamivir Prophylaxis on Influenza Transmission in Nursing Homes

National Institute for Public Health and the Environment (RIVM)1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
900
试验地点
1
主要终点
Transmission of influenza from person to person

研究概览

简要总结

The incidence of severe morbidity and mortality following an influenza infection during the annual influenza epidemics is highest among the elderly population and 90% of influenzaassociated mortality occurs in this group. Vaccination is considered the best preventive intervention available but offers only partial protection. The protective effect decreases with advancing age and existing co-morbidity. Therefore, in spite of high compliance with vaccination, the risk of influenza-related complications among nursing-home residents, is particularly high, and consequently also the associated disease and economic burden. There is debate on the potential health benefit of the antiviral activity of oseltamivir as an effective supplementary intervention to prevent or contain influenza outbreaks in nursing homes. Although effectiveness of post-exposure prophylaxis (PEP) with oseltamivir on preventing transmission has been demonstrated in trials among healthy (mainly unvaccinated) adults and children, effectiveness has not yet been assessed among vulnerable vaccinated highrisk groups, such as the elderly population in nursing homes. If proven (cost)effective, oseltamivir could have considerable benefits in this setting, although constraints relating to implementation need to be addressed as well.

详细描述

Objective If proven (cost)effective, without inducing antiviral resistance, oseltamivir could have considerable benefits in this setting, although constraints relating to implementation need to be addressed as well. If not (cost)effective if this fragile population, resources can be better spent on other activities to support nursing home residents.

Study design:

A randomised controlled trial on the effect of PEP with oseltamivir versus placebo on transmission of influenza in nursing homes, linked to virological monitoring of possible development of resistance and impact on transmission and outcome, linked with a cost effectiveness analysis, and an exploration of logistical and ethical issues which could interfere with successful implementation.

Study population:

This trial will be nested in the recently established Network of Nursing Homes (SNIV). SNIV has been initiated and is coordinated by the RIVM Centre of Infectious Disease Control. Baseline data on the population in these nursing homes is already routinely collected, and epidemiological and virological surveillance of ILI/influenza is established, in collaboration with the local laboratories.

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
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Kidney dialyses

研究组 & 干预措施

Tamiflu

Active Comparator

干预措施: Tamiflu (verum) (Drug)

Placebo Tamiflu

Placebo Comparator

干预措施: Tamiflu placebo (Drug)

结局指标

主要结局

Transmission of influenza from person to person

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
National Institute for Public Health and the Environment (RIVM)
申办方类型
Other Gov

研究点 (1)

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