A Controlled Trial of Masks and Hand Hygiene for Reducing Influenza Transmission

口罩和手部卫生减少流感传播的对照试验

• 批准号: 7266661
• 负责人: K. GABRIEL LEUNG
• 金额: $ 32.52万
• 依托单位: UNIVERSITY OF HONG KONG
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7266661
• 关键词: antiseptic sterilization; clinical research; clinical trials; communicable disease control; communicable disease transmission; cooperative study; health behavior; household; human subject; influenza; patient oriented research; questionnaires; surgery material /equipment

DESCRIPTION (provided by applicant): Broad objectives: To study the community transmission dynamics of influenza in a subtropical city state. Specific aims of this proposal: To assess the efficacy of face masks and/or hand hygiene in reducing household transmission of influenza. Summary of proposed study: Design and subjects: A cluster randomized controlled trial of 1,477 households where one resident has symptoms of influenza-like-illness (index patient). The 1,477 households will include 1,477 index patients and 4,136 'secondary contacts'. After recruitment of an index patient, a study nurse will visit the household to administer the intervention, and will revisit after 3, 6 and 9 days. We will conduct an initial pilot involving 120 households to confirm feasibility and logistics before implementation of the main study. Interventions: 1, placebo (educational talk on upper respiratory tract illness self-care); 2, placebo plus distribution of free masks and education on their use; 3, placebo plus distribution of alcohol hand rubs/dispensers and education on hand hygiene; 4, placebo plus face masks and alcohol rubs/dispensers hand hygiene interventions. Instruments: Initial assessment of influenza in an index patient will be made using the QuickVue rapid diagnostic test. Clinical influenza in secondary contacts will be assessed by self-reported symptoms. Nose and throat swabs will be collected from index patients and secondary contacts for laboratory confirmation of influenza. Main outcome measures: The proportion of secondary contacts with influenza (laboratory definition where samples are available, otherwise clinical definition) during the 10 days following randomization. Relevance: The results of this study will have important implications for influenza prevention in the community locally and globally. Moreover in light of recent fears of a new influenza pandemic, our results will inform public health policy on non-pharmaceutical interventions in a subtropical Chinese setting.

描述（由申请人提供）： 总体目标：研究亚热带城市国家流感的社区传播动态。该提案的具体目标：评估口罩和/或手部卫生在减少流感家庭传播方面的功效。拟议研究摘要： 设计和受试者：一项针对 1,477 个家庭的整群随机对照试验，其中一名居民出现流感样疾病症状（指标患者）。这 1,477 个家庭将包括 1,477 名指标患者和 4,136 名“第二接触者”。招募指标患者后，研究护士将访问该家庭进行干预，并将在 3、6 和 9 天后再次访问。在进行主要研究之前，我们将进行一项涉及120户家庭的初步试点，以确认可行性和物流。干预措施：1、安慰剂（上呼吸道疾病自我保健教育讲座）； 2、安慰剂加免费口罩的分发和使用教育； 3、安慰剂加分发酒精搓手液/分配器以及手部卫生教育； 4、安慰剂加口罩和酒精擦/分配器手部卫生干预措施。仪器：将使用 QuickVue 快速诊断测试对指示患者的流感进行初步评估。二次接触者的临床流感将通过自我报告的症状进行评估。将从指示患者和二次接触者身上采集鼻咽拭子，用于流感实验室确认。主要结果指标：随机分组后 10 天内二次接触流感的比例（有样本的实验室定义，否则临床定义）。相关性：这项研究的结果将对当地和全球社区的流感预防产生重要影响。此外，鉴于最近对新的流感大流行的担忧，我们的结果将为中国亚热带地区非药物干预的公共卫生政策提供信息。