a Randomized Controlled Trial Evaluating the Effectiveness and the Safety of Surgical Masks Wared by the Index Patient for Preventing Secondary Transmission of Influenza A in Households
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- The number of household contacts who will develop within 7 days of the inclusion of the index patient a respiratory syndrome defined by fever> = 37.8 ° C and a cough or a sore throat.
研究概览
简要总结
This work aims to measure the effectiveness of face mask worn by a patient with flu to avoid transmission to other persons in the household.
详细描述
Background. Non pharmaceutical interventions, and in particular the wearing of face masks, could play a role in controlling the transmission of influenza in the early stages of the epidemic. In the French pandemic plan, surgical masks are recommended in contagious patients in wards. The effectiveness of such masks in preventing transmission of influenza A virus is unknown. Our project aims to assess the preventive efficacy and tolerance of surgical mask.
The primary objective is to measure the decrease of the number of secondary cases of flu in households where the index case will wear a surgical mask during its period of infectiousness (5 days), compared to households where the index case will not be subject to this intervention. Secondary objectives are: (1) to study the feasibility and tolerance of wearing a mask continuously during the period of viral shedding; (2) virological description of infection spreading among household contacts based on virological collections.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient seeking medical advice for:
- •For symptoms less than 48 hours, combining fever> = 37.8 ° C and a cough,
- •during the period of a seasonal influenza epidemic (as defined by the Sentinel network)
- •Older than 5 years
- •And living in a household size between 3 to 8..
- •The patient is the first case in the household (index patient). The patient has a positive rapid influenza A test.
- •Informed consent.
- •Affiliation to the social security.
排除标准
- •When concomitant influenza cases are known in other householders
- •When the patient is suffering from asthma or COPD (ongoing treatment):
- •Hospitalization.
- •Treatment by a neuraminidase inhibitor.
结局指标
主要结局
The number of household contacts who will develop within 7 days of the inclusion of the index patient a respiratory syndrome defined by fever> = 37.8 ° C and a cough or a sore throat.
时间窗: during the study
次要结局
- Quality of life in the index patient.(during the study)
- Drug-consumption, in particular antibiotics(during the study)
- Sick-leave from work (for adults contacts), or from school (for children of school age).(during the study)
- clinical events in all household members on the entire monitoring period (21 days).(21 days)
- Adverse events related to wearing a mask - a safety issue.(during the study)
- Number of days of wearing a mask, number of masks used.(during the study)
- Infection with influenza virus at different time, among all household members.(during the study)
- Quantification of viral load in patients infected.(during the study)
- Characterization of viruses isolated (sub-type and sequence of the portion of HA1 gene for haemagglutinin).(during the study)