Effects of a comprehensive antibiotic stewardship program on antibiotic prescribing for acute respiratory infections in rural facilities: a cluster randomized trial

Antimicrobial resistance is driven by inappropriate use of antibiotics for acute respiratory infections (ARIs), which is a major challenge in primary care in low- and middle-income countries. Here we conducted a pragmatic, cluster randomized controlled trial in 34 township hospitals in two rural counties of Guangdong, China, to evaluate whether a digitally enabled stewardship program could reduce antibiotic prescribing. The intervention combined training and guidelines for doctors; concise, evidence-based guidelines embedded in the electronic medical record with point-of-care prompts; monthly prescribing peer review feedback for doctors; and patient education delivered through a smartphone app. Control is usual care with no inputs. During the 12-month implementation period (1 March 2020 to 28 February 2021), we analyzed 97,239 eligible consultations for ARIs. The primary outcome was whether a consultation resulted in any antibiotics being prescribed. This outcome was met: antibiotics were prescribed in 26% (14,521/54,799) of intervention consultations compared to 71% (30,340/42,440) of control consultations, yielding an adjusted risk difference of -39 percentage points (95% confidence interval: -47 to -29; P < 0.001). There was no evidence of increased harm, as 30-day hospitalization rates for respiratory illness or sepsis did not differ between groups (adjusted risk difference, 0.2 percentage points; 95% confidence interval: -0.3 to 0.6). A comprehensive stewardship program can substantially reduce inappropriate antibiotic prescribing for ARIs in rural primary care facilities in China without compromising patient safety. Trial registration: ISRCTN96892547.