Effect of a comprehensive package based on combined C-reactive protein and serum amyloid A point-of-care testing on antibiotic prescribing for acute respiratory tract infections at village clinics in China: a cluster randomised controlled trial.

Background: Antibiotic misuse is a key driver of antimicrobial resistance globally, with high rates of inappropriate use observed in rural China. We evaluated the effectiveness of a comprehensive package based on quantified point-of-care testing (POCT) for C-reactive protein and serum amyloid A (CRP&SAA) in reducing inappropriate antibiotic use for acute respiratory infections (ARIs) in village clinics in rural China. Methods: We conducted a pragmatic, parallel-group, cluster-randomised controlled trial at 40 village clinics in Xiantao City, Hubei Province, China, over a 6-month intervention period. Village clinics were randomly assigned (1:1) to provide a comprehensive package based on CRP&SAA POCT, or usual care. Randomisation was stratified by township. Eligible consultations were patients of all ages with a diagnosis of ARI or acute respiratory symptoms in village clinics. The primary outcome was the proportion of initial patient consultations diagnosed with ARIs resulting in any antibiotic prescriptions from village doctors in the intention-to-treat population. The 30-day hospital admission rate for ARIs or sepsis following the initial ARI consultation was measured as a safety outcome. This trial is registered with ClinicalTrials.gov, NCT06568432. Findings: Forty village clinics were randomly assigned, 20 to the intervention group (n = 17,754) and 20 to the control group (n = 17,354). A total of 7.4% consultations (1311 out of 17,754) performed the test in the intervention group. A total of 9001 (50.70%) consultations in the intervention group and 11,715 (67.51%) consultations in the control group resulted in antibiotic prescriptions (adjusted relative risk 0.80 [95% CI 0.78-0.82; p < 0.001]; adjusted risk difference -13% [95% CI -15 to -12; p < 0.001]). The 30-day hospitalisation rate for ARIs or sepsis did not differ significantly (0.32% in the control group versus 0.35% in the intervention group; adjusted relative risk 0.94 [95% CI 0.59-1.48; p = 0.78]; adjusted risk difference 0% [95% CI 0-0; p = 0.78]). Interpretation: The interventions can safely and effectively reduce antibiotic use among patients with ARIs in village clinics in rural China. Future implementation efforts should further examine the barriers and facilitators to adopting POCT within specific health system contexts and service delivery settings, and identify cost-effective strategies to scale up POCT in primary care. Funding: The University of Toronto-Huazhong University of Science and Technology JOINT SEED FUND and the Medical Young Top-notch Talent Cultivation Program of Hubei Province.