RSV-associated acute otitis media in children under five years old: a systematic review and meta-analysis

Background: Respiratory syncytial virus (RSV) is a leading cause of infant respiratory infections and an important contributor to acute otitis media (AOM) development. We aimed to synthesise evidence on RSV-associated AOM to support research to reduce its morbidity. Methods: In April 2025, we performed a systematic review and meta-analysis by searching the Embase, MEDLINE, and Global Health databases to identify studies reporting RSV-associated AOM in children aged 0-60 months. We extracted the proportions of RSV infections complicated by AOM, the proportions of AOM-associated samples with RSV detected, and the odds ratios for factors associated with AOM development in RSV-positive children. Results: Pooled estimates revealed 27.7% (95% confidence interval (CI) = 12.4-50.7) of RSV infections were complicated by AOM. RSV was detected in 23.6% (95% CI = 14.8-35.5) of AOM-associated samples, with detection rates slightly higher in nasopharyngeal samples 22.2% (95% CI = 13.2-34.8) than middle ear fluid samples 18.8% (95% CI = 6.6-42.9). Bacterial co-infections were present in 70.1% (95% CI = 43.4-87.7) of RSV-positive middle ear fluid samples among children with AOM. Factors associated with AOM development in RSV-positive children included high viral load, Streptococcus pneumoniae co-infection, being aged between 3 and 12 months, and fever. Conclusions: RSV is a prominent viral contributor to AOM pathogenesis; however, significant heterogeneity and methodological differences across studies limit the accuracy and generalisability of findings. Standardised prospective studies are needed to further investigate risk stratification and evaluate the effectiveness of interventions to prevent RSV-associated AOM and improve its management. Registration: PROSPERO: CRD42025642807.