Department of Medical Biotechnology, College of Applied Medical Sciences, Qassim University, Buraydah 51452, Saudi Arabia.
National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia; Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, NSW 2145, Australia; Department of Public Health, College of Health Sciences, Saudi Electronic University, Jeddah 23442, Saudi Arabia.
J Infect Public Health. 2024 Apr;17 Suppl 1:34-41. doi: 10.1016/j.jiph.2023.04.003. Epub 2023 Apr 7.
There is a lack of randomised controlled trials (RCTs) investigating the role of hand hygiene in preventing and containing acute respiratory infections (ARIs) in mass gatherings. In this pilot RCT, we assessed the feasibility of establishing a large-scale trial to explore the relationship between practising hand hygiene and rates of ARI in Umrah pilgrimage amidst the COVID-19 pandemic.
A parallel RCT was conducted in hotels in Makkah, Saudi Arabia, between April and July 2021. Domestic adult pilgrims who consented to participate were randomised 1:1 to the intervention group who received alcohol-based hand rub (ABHR) and instructions, or to the control group who did not receive ABHR or instructions but were free to use their own supplies. Pilgrims in both groups were then followed up for seven days for ARI symptoms. The primary outcome was the difference in the proportions of syndromic ARIs among pilgrims between the randomised groups.
A total of 507 (control: intervention = 267: 240) participants aged between 18 and 75 (median 34) years were randomised; 61 participants were lost to follow-up or withdrew leaving 446 participants (control: intervention = 237:209) for the primary outcome analysis; of whom 10 (2.2 %) had developed at least one respiratory symptom, three (0.7 %) had 'possible ILI' and two (0.4 %) had 'possible COVID-19'. The analysis of the primary outcome found no evidence of difference in the proportions of ARIs between the randomised groups (odds ratio 1.1 [0.3-4.0] for intervention relative to control).
This pilot trial suggests that conducting a future definitive RCT to assess the role of hand hygiene in the prevention of ARIs is feasible in Umrah setting amidst such a pandemic; however, outcomes from this trial are inconclusive, and such a study would need to be very large given the low rates of outcomes observed here.
This trial was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12622001287729), the full protocol can be accessed there.
目前缺乏关于手部卫生在预防和控制大规模集会中急性呼吸道感染（ARI）方面作用的随机对照试验（RCT）。在这项初步 RCT 中，我们评估了在 COVID-19 大流行期间开展一项大规模试验以探索在朝觐期间进行手部卫生实践与 ARI 发生率之间关系的可行性。
2021 年 4 月至 7 月，在沙特阿拉伯麦加的酒店进行了一项平行 RCT。同意参加的国内成年朝圣者被随机分配至干预组（接受酒精基手部消毒剂（ABHR）和指导）或对照组（不接受 ABHR 或指导，但可自由使用自己的用品）。两组朝圣者均随访 7 天，以监测 ARI 症状。主要结局是随机分组的朝圣者中综合征性 ARI 的比例差异。
共纳入 507 名（对照组：干预组=267：240）年龄在 18 至 75 岁之间（中位数 34 岁）的参与者；61 名参与者失访或退出，446 名参与者（对照组：干预组=237：209）进行了主要结局分析；其中 10 名（2.2%）出现了至少一种呼吸道症状，3 名（0.7%）出现了“可能的 ILI”，2 名（0.4%）出现了“可能的 COVID-19”。主要结局分析未发现随机分组的 ARI 比例存在差异（干预组相对于对照组的比值比 1.1[0.3-4.0]）。
这项初步试验表明，在 COVID-19 大流行期间，在朝觐环境中开展评估手部卫生在预防 ARI 中的作用的未来确定性 RCT 是可行的；然而，该试验的结果尚无定论，鉴于此处观察到的结局发生率较低，此类研究需要非常大规模。
该试验在澳大利亚新西兰临床试验注册中心（ANZCTR）（ACTRN12622001287729）注册，可以在那里获取完整的方案。
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