Facemask against viral respiratory infections among Hajj pilgrims: a\ua0challenging clusterrandomized trial

Background In this large-scale cluster-randomized controlled trial (cRCT) we sought to assess the effectiveness of facemasks against viral respiratory infections. Methods and results Over three consecutive Hajj seasons (2013, 2014, 2015) pilgrims' tents in Makkah were allocated to 'facemask' or 'no facemask' group. Fifty facemasks were offered to participants in intervention tents, to be worn over four days, and none were offered to participants in control tents. All participants recorded facemask use and respiratory symptoms in health diaries. Nasal swabs were collected from the symptomatic for virus detection by reverse transcription polymerase chain reaction. Clinical symptoms and laboratory results were analyzed by 'intention- to-treat' and 'per-protocol'. A total of 7687 adult participants from 318 tents were randomized: 3864 from 149 tents to the intervention group, and 3823 from 169 tents to the control group. Participants were aged 18 to 95 (median 34, mean 37) years, with a male to female ratio of 1:1.2. Overall, respiratory viruses were detected in 277 of 650 (43%) nasal/ pharyngeal swabs collected from symptomatic pilgrims. Common viruses were rhinovirus (35.1%), influenza (4.5%) and parainfluenza (1.7%). In the intervention arm, respectively 954 (24.7%) and 1842 (47.7%) participants used facemasks daily and intermittently, while in the control arm, respectively 546 (14.3%) and 1334 (34.9%) used facemasks daily and intermittently. By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40). Similarly, in a per-protocol analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (OR 1.2, 95% CI 0.9-1.7, p = 0.26) nor against clinical respiratory infection (OR 1.3, 95% CI 1.0-1.8, p = 0.06). Conclusion This trial was unable to provide conclusive evidence on facemask efficacy against viral respiratory infections most likely due to poor adherence to protocol. Copyright

Changes in the prevalence of influenza-like illness and influenza vaccine uptake among Hajj pilgrims: A 10-year retrospective analysis of data

Background: Influenza is an important health hazard among Hajj pilgrims. For the last ten years, pilgrims are being recommended to take influenza vaccine before attending Hajj. Vaccination coverage has increased in recent years, but whether there has been any change in the prevalence of influenza-like illness (ILI) is not known. In this analysis, we examined the changes in the rate of ILI against seasonal influenza vaccine uptake among Hajj pilgrims over the last decade. Method: Data for this analysis is a synthesis of raw and published data from eleven Hajj seasons between 2005 and 214. For seven Hajj seasons the data were obtained from studies involving pilgrims of UK, Saudi Arabia and Australia; and for the remaining four Hajj seasons data were abstracted from published studies involving pilgrims from multiple countries. The data from both sources were synthesised to estimate the relative risk (RR) of acquisition of ILI in vaccinated versus unvaccinated pilgrims. Results: The pooled sample size of the included studies was 33,213 with most pilgrims being in the age band of 40-60 years (range: 0.5 to 95 years) and a male to female ratio of 1.6. The pilgrims originated, in order of frequency, from Iran, Australia, France, UK, Saudi Arabia, Indonesia, India, Algeria, Ivory Coast, Nigeria, Somalia, Turkey, Syria, Sierra Leone and USA. Except for one year (2008), data from individual years did not demonstrate a noticeable change in the rate of ILI against influenza vaccine coverage, however the combined data from all studies suggest that the prevalence of ILI decreased among Hajj pilgrims as the vaccine coverage increased over the last decade (RR 0.2,