Registered trials for healthcare-associated infections prevention in intensive care units, 2000-2025

Healthcare-associated infections (HAIs) are a major source of morbidity in intensive care units (ICUs), yet the characteristics of clinical trials evaluating preventive interventions remain poorly investigated. This study aimed to map trends, features and transparency of registered clinical trials on HAI prevention in ICUs, and identify factors associated with early trial discontinuation. Cross-sectional analysis of clinical trials registered between 2000 and 2025 in major trial registries. Multivariable logistic regression was used to identify predictors of early trial discontinuation. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. Overall, 428 trials were included, of which 56.5% had HAI prevention as a primary outcome. Trial registration increased over time, with a mean of 16.5 trials per year. Most studies were randomized (89.3%) and conducted in adult ICUs (81.8%). Procedural interventions were the most common (34.3%), whereas behavioral or bundle interventions were underrepresented (7.0% and 9.3%). Respiratory infections were the most frequently targeted HAIs (39.7%). Industry sponsorship was rare (4.9%). Transparency was limited: 17.1% of trials had a protocol available, and among those reporting data availability (47.0%), most declared no intention to share data (62.4%). Only 39.5% of trials had published their results (mean time to submission: 4.5 years). Trials conducted in high-income countries were more likely to be discontinued early (aOR 4.45; 95% CI 1.24–16.00), while device- (aOR 0.37; 95% CI 0.14–1.00) and practice-based interventions (aOR 0.22; 95% CI 0.09–0.55) were less likely to be discontinued than pharmacological trials. Despite increasing registration, trials on HAI prevention in ICUs remain insufficient in volume and transparency. Underrepresentation of key strategies and major reporting shortcomings limit the evidence base, highlighting the need for more robust, timely, and policy-relevant IPC research.

Key messages

• HAI prevention trials in ICUs are scarce, underreported, and poorly transparent - a gap disproportionate to the global burden of healthcare-associated infections.

• Behavioral and bundle interventions remain critically understudied; intervention type - not sponsorship - is the key driver of early trial discontinuation.