Impact of pharmaceutical intervention on the use of intravenous antibiotics in patients with bacterial upper respiratory tract infections: protocol for a cluster-randomized controlled trial.

BACKGROUND

Overuse of antibiotics among patients with upper respiratory tract infections (URTIs) is a worldwide problem. In China, approximately 70% of outpatients with URTIs are treated with antibiotics, often via intravenous infusion. This study aimed to evaluate whether a pharmacist-led multidimensional intervention reduces the use of intravenous (IV) antibacterial drug infusion among patients with bacterial URTIs.

METHODS AND ANALYSIS: This study employed a pragmatic, parallel controlled, cluster-randomized superiority trial design. Outcome assessment and data analysis were conducted in a blinded manner, while treatment administration remained unblinded. A total of 28 hospitals in Zhejiang Province, China, were randomly allocated in a 1:1 ratio. In the intervention arm, a multidimensional intervention embedded in routine emergency treatment will be applied, involving both doctors and patients. The interventions included systematic physician training, clinical decision support cards, and printed educational materials for patients. Patients admitted to the sites assigned to the control arm will receive usual care at the discretion of treating physicians. The primary outcome was the rate of intravenous antibacterial drug infusion during the index admission. Secondary outcomes included the duration of URTI symptoms, adverse events, proportion of eligible patients who received subsequent antibiotics, frequency of re-consultation, and hospitalization within the follow-up period. The final follow-up was completed by 14 days post-discharge. Participants will be included from August 1, 2025, to January 31, 2026.

CONCLUSION

This study will demonstrate the feasibility and potential impact of a pharmacist-led, multidimensional intervention aimed at reducing IV antimicrobial use in patients with bacterial URTIs.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT06620341.