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
Chen, S., Ko, W., Li, W. , Xiao, R., Du, F., Zhang, J., Wu, S., Zheng, B., Zhu, N. J., Ahmad, R.
ORCID: 0000-0002-4294-7142, Little, P., Guan, X., Shi, L. & Wushouer, H. (2025).
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.
BMJ Open, 15(11),
article number e106008.
doi: 10.1136/bmjopen-2025-106008
Abstract
Introduction
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.
Methods and analysis
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 and dissemination
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.
| Publication Type: | Article |
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| Additional Information: | © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/. |
| Publisher Keywords: | Humans, Respiratory Tract Infections, Anti-Bacterial Agents, Adult, Primary Health Care, China, Male, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Inappropriate Prescribing, Pragmatic Clinical Trials as Topic, Practice Patterns, Physicians', Antibiotics, China, Primary Health Care, Respiratory infections, Humans, Anti-Bacterial Agents, China, Primary Health Care, Respiratory Tract Infections, Multicenter Studies as Topic, Inappropriate Prescribing, Pragmatic Clinical Trials as Topic, Adult, Practice Patterns, Physicians', Male, Randomized Controlled Trials as Topic, 1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences, 32 Biomedical and clinical sciences, 42 Health sciences, 52 Psychology |
| Subjects: | R Medicine > R Medicine (General) R Medicine > RM Therapeutics. Pharmacology R Medicine > RS Pharmacy and materia medica |
| Departments: | School of Health & Medical Sciences School of Health & Medical Sciences > Department of Population Health & Policy |
| SWORD Depositor: |
Available under License Creative Commons Attribution Non-commercial.
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