Study protocol for evaluating delayed antibiotic prescribing to promote rational antibiotic use in primary healthcare institutions in China: a pragmatic, multicentre, open-label, clustered-randomised controlled trial.

Abstract

Delayed antibiotic prescribing (DAP) has demonstrated efficacy in reducing inappropriate antibiotic use for uncomplicated respiratory tract infections (uRTIs) in primary care across high-income countries. However, evidence regarding its effectiveness in low-income and middle-income countries remains limited. This cluster-randomised controlled trial (cRCT) aims to evaluate the effectiveness of DAP for optimising antibiotic use in primary healthcare institutions (PHIs) in China. We designed a pragmatic, multicentre, open-label, three-arm cRCT in adult patients with uRTIs. The study will involve 12 PHIs in Korla City of China. Participating institutions will be randomised at a 1:1:1 ratio to three parallel arms: (1) DAP-intervention arm, (2) Immediate antibiotic prescribing comparator arm and (3) Usual care (observational arm). The primary outcome is symptom duration. Secondary outcomes include symptom severity, antibiotic use, adverse events, patient satisfaction and patient belief regarding antibiotic efficacy. Ethics committee approval of this study was obtained from Peking University Institution Review Board (IRB00001052-24169). The findings will be disseminated through peer-reviewed publications and presentations at scientific conferences. ChiCTR2500097330.