Rationale Medical masks are commonly used by sick individuals with influenza-like illness (ILI) to prevent spread of infections to others, but clinical efficacy data are absent.
Objective Determine whether medical mask use by sick individuals with ILI protects well contacts from related respiratory infections.
Setting 6 major hospitals in 2 districts of Beijing, China.
Design Cluster randomised controlled trial.
Participants 245 index cases with ILI.
Intervention Index cases with ILI were randomly allocated to medical mask (n=123) and control arms (n=122). Since 43 index cases in the control arm also used a mask during the study period, an as-treated post hoc analysis was performed by comparing outcomes among household members of index cases who used a mask (mask group) with household members of index cases who did not use a mask (no-mask group).
Main outcome measure Primary outcomes measured in household members were clinical respiratory illness, ILI and laboratory-confirmed viral respiratory infection.
Results In an intention-to-treat analysis, rates of clinical respiratory illness (relative risk (RR) 0.61, 95% CI 0.18 to 2.13), ILI (RR 0.32, 95% CI 0.03 to 3.13) and laboratory-confirmed viral infections (RR 0.97, 95% CI 0.06 to 15.54) were consistently lower in the mask arm compared with control, although not statistically significant. A post hoc comparison between the mask versus no-mask groups showed a protective effect against clinical respiratory illness, but not against ILI and laboratory-confirmed viral respiratory infections.
Conclusions The study indicates a potential benefit of medical masks for source control, but is limited by small sample size and low secondary attack rates. Larger trials are needed to confirm efficacy of medical masks as source control.
Trial registration number ACTRN12613000852752; Results.
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Contributors CRM was the lead investigator, and was responsible for conception and design of the study, analysing data and writing the manuscript. YZ was involved in implementation and database management. AAC was involved in statistical analysis and drafting of manuscript. HS, DZ, YC and HZ were involved in recruitment and training, manuscript revision. BR contributed to the statistical analysis and revision of manuscript. QW was involved in implementation, contribution to design, analysis and drafting of paper.
Funding This study was supported by a UNSW Goldstar award.
Competing interests All authors have completed the Unified Competing Interests form (available on request from the corresponding author) and declare that: CRM has held an Australian Research Council Linkage Grant with 3M as the industry partner, for investigator driven research. 3M have also contributed supplies of masks and respirators for investigator-driven clinical trials. She has received research grants and laboratory testing as in-kind support from Pfizer, GSK and Bio-CSL for investigator-driven research. HS had an NHMRC Australian based Public Health Training Fellowship at the time of the study (1012631). She has also received funding from vaccine manufacturers GSK, bio-CSL and Saniofi Pasteur for investigator-driven research and presentations. AAC had testing of filtration of masks by 3M for PhD.
Patient consent Obtained.
Ethics approval Beijing Center for Disease Prevention and Control IRB and the Human Research Ethics Committee of the University of New South Wales (UNSW), Australia (HREC approval number HC13236).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.