BACKGROUND/

objectivesAlthough

methodsSix databases (three global [PubMed, Embase, Cochrane] and three Chinese [Chinese National Knowledge Infrastructure, Chinese Science Citation, Wanfang]) were searched on 5 August 2025 using CDI-related and epidemiological search terms. No date or language limits were applied. Real-world epidemiologic studies of adults and/or children with laboratory-confirmed CDI in mainland China reporting population-based CDI incidence, hospital-based CDI incidence, and/or CDI admission rates were included. All studies not meeting these criteria were excluded. Risk-of-bias (RoB) assessment was performed using the Newcastle-Ottawa Scale. Results were summarized descriptively.

resultsIn total, 11 articles formed the evidence base for this review; each was a single-center, hospital-based study conducted in one of six cities in mainland China and published between 2014 and 2023. RoB assessment indicated that the evidence base was appropriate for this study. No study reported population-based CDI incidence. In total, 10 studies reported hospital-based CDI incidence (0 to 82.0/10,000 patient-days), and four reported CDI admission rates (0 to 23.1/1000 admissions). Eight studies reported mortality rates, which varied across studies.

conclusionsSeveral single-center, hospital-based studies demonstrate that CDI is present in hospitals in mainland China, but there are no published population-based CDI incidence estimates. These results should be interpreted considering this study's limitations, including potential publication and selection bias, heterogeneity, and limited generalizability. Overall, the burden of CDI is poorly understood in mainland China. Thus, prospective epidemiological studies, including those with sensitive detection methods, are needed to examine CDI burden across multiple cities in mainland China. These efforts would help illuminate the CDI burden and guide prevention efforts. (PROSPERO ID 1140152; registered 17 March 2026; funding by Pfizer Inc.).