Wang Mandy, Barasheed Osamah, Rashid Harunor, Booy Robert, El Bashir Haitham, Haworth Elizabeth, Ridda Iman, Holmes Edward C, Dwyer Dominic E, Nguyen-Van-Tam Jonathan, Memish Ziad A, Heron Leon
National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.
National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.
J Epidemiol Glob Health. 2015 Jun;5(2):181-9. doi: 10.1016/j.jegh.2014.08.002. Epub 2014 Oct 2.
Cost-effective interventions are needed to control the transmission of viral respiratory tract infections (RTIs) in mass gatherings. Facemasks are a promising preventive measure, however, previous studies on the efficacy of facemasks have been inconclusive. This study proposes a large-scale facemask trial during the Hajj pilgrimage in Saudi Arabia and presents this protocol to illustrate its feasibility and to promote both collaboration with other research groups and additional relevant studies.
METHODS/DESIGN: A cluster-randomised controlled trial is being conducted to test the efficacy of standard facemasks in preventing symptomatic and proven viral RTIs among pilgrims during the Hajj season in Mina, Mecca, Saudi Arabia. The trial will compare the 'supervised use of facemasks' versus 'standard measures' among pilgrims over several Hajj seasons. Cluster-randomisation will be done by accommodation tents with a 1:1 ratio. For the intervention tents, free facemasks will be provided to be worn consistently for 7days. Data on flu-like symptoms and mask use will be recorded in diaries. Nasal samples will be collected from symptomatic recruits and tested for nucleic acid of respiratory viruses. Data obtained from questionnaires, diaries and laboratory tests will be analysed to examine whether mask use significantly reduces the frequency of laboratory-confirmed respiratory viral infection and syndromic RTI as primary outcomes.
This trial will provide valuable evidence on the efficacy of standard facemask use in preventing viral respiratory tract infections at mass gatherings. This study is registered at the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12613001018707 (http://www.anzctr.org.au).
需要具有成本效益的干预措施来控制大规模集会中病毒性呼吸道感染（RTIs）的传播。口罩是一种很有前景的预防措施，然而，先前关于口罩功效的研究尚无定论。本研究提议在沙特阿拉伯麦加朝觐期间进行一项大规模口罩试验，并展示此方案以说明其可行性，促进与其他研究团队的合作以及开展更多相关研究。
方法/设计：正在进行一项整群随机对照试验，以测试标准口罩在沙特阿拉伯麦加米纳朝觐季节预防朝圣者出现有症状且经证实的病毒性呼吸道感染方面的功效。该试验将在多个朝觐季节比较朝圣者中“监督使用口罩”与“标准措施”的效果。整群随机分组将按1:1的比例通过住宿帐篷进行。对于干预组帐篷，将提供免费口罩，要求连续佩戴7天。流感样症状和口罩使用情况的数据将记录在日记中。将从有症状的招募者中采集鼻拭子样本，检测呼吸道病毒核酸。将对从问卷、日记和实验室检测中获得的数据进行分析，以检验口罩使用是否能显著降低实验室确诊的呼吸道病毒感染和症状性呼吸道感染的发生率，并将其作为主要结果。
该试验将为标准口罩在预防大规模集会中病毒性呼吸道感染方面的功效提供有价值的证据。本研究已在澳大利亚新西兰临床试验注册中心（ANZCTR）注册，注册号：ACTRN12613001018707（http://www.anzctr.org.au）。
