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BACKGROUND: Non-ventilator hospital-acquired pneumonia (NV-HAP) is among the most prevalent health-care-associated infections, yet remains under-reported, understudied, and infrequently targeted by infection prevention strategies. Oral care is considered a key preventive measure; however, there are few high-quality randomised controlled trials conducted in hospital settings. The aim of this study is to evaluate whether an enhanced oral care intervention reduces the incidence of NV-HAP. METHODS: The Hospital Acquired Pneumonia Prevention (HAPPEN) trial was an open-cohort, stepped-wedge, cluster-randomised trial conducted across three Australian hospitals. Large public or private hospitals were eligible. Simple randomisation was used to allocate nine wards (clusters) across three treatment sequences. All patients aged 18 years or older admitted to a trial cluster were eligible, with outcomes assessed for patients admitted for at least 48 h. The intervention comprised three components: enhanced delivery of oral care and provision of products, patient and staff education, and audit and feedback, delivered by dedicated research nurses. The control was usual practice-ie, oral care performed by health-care workers as per hospital policy. Primary and secondary outcomes were analysed in the intention-to-treat population. The primary outcome was NV-HAP incidence, defined according to European Centre for Disease Prevention and Control criteria. Secondary outcomes included hospital-acquired lower and upper respiratory tract infections and oral cavity infections. Outcomes were defined using established definitions and determined following a review of medical records. This study was single blinded, with data collectors masked to allocated treatment sequences. The completed trial is registered with the Australia New Zealand Clinical Trials Registry (ACTRN12624000187549). FINDINGS: The trial was conducted from June 3, 2024, to Aug 22, 2025. A total of 12 446 admitted patients were eligible to receive the intervention, 3336 of whom were excluded because they were admitted to a trial cluster for less than 48 h. A total of 8870 patients were analysed, with 4523 exposed to the control condition and 4347 exposed to the intervention condition. NV-HAP was confirmed in 78 (0·9%) of 8870 patients: 46 (1·0%) of 4523 under the control condition and 32 (0·7%) of 4347 under the intervention condition. Intervention exposure was associated with a cumulative hazard ratio of 0·40 (95% CI 0·19-0·82), representing a decrease from 1·00 to 0·41 infections per 100 admission-days at risk. Intervention exposure resulted in a cumulative hazard ratio of 1·64 (95% CI 0·61-4·39) for lower or upper respiratory tract infection, and 1·08 (0·66-1·77) for oral cavity infection. The proportion of participants who completed the oral care protocol increased from 474 (15·9%) of 2988 to 1727 (61·9%) of 2791 following intervention exposure. INTERPRETATION: This multicentre randomised controlled trial demonstrates that improving oral care reduces NV-HAP incidence among hospitalised patients, compared with usual care. Our findings provide novel and clinically important evidence to inform future prevention guidelines and hospital infection control policy. FUNDING: Medical Research Future Fund.
White et al. (Mon,) studied this question.