Xu Minzhi, Zhang Zhitong, Ge Erjia, Xie Charis Xuan, Bai Xinyu, Zhu Yuting, Kuang Guangjin, Li Jinxi, Wang Jing, Wei Xiaolin, Yin Xiaoxv
Department of Social Medicine and Health Management, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
PLoS One. 2025 Sep 8;20(9):e0331646. doi: 10.1371/journal.pone.0331646. eCollection 2025.
Antimicrobial resistance is a globally recognised public health threat. In rural China, antibiotic use is common for acute respiratory infections (ARIs), which include symptoms such as coughing and fever that are most likely viral infections but with a small proportion as bacterial infections. This study aims to evaluate the effectiveness of a comprehensive intervention based on C-reactive protein and serum amyloid A point-of-care testing (CRP&SAA POCT) in reducing the inappropriate use of antibiotics for ARIs in Chinese village clinics.
This is a pragmatic, parallel-group, controlled, cluster-randomised, superiority trial featuring blinded outcome evaluation and data analysis, along with unblinded treatment. This study will be conducted over a period of six months across 40 village clinics in Hubei, China. CRP&SAA POCT will be implemented in 20 village clinics within the intervention arm. This will include additional training for village doctors on the operations of CRP&SAA POCT, which encompasses centralised training, the distribution of training manuals, and desk reminders. Patient education materials will be provided to assist patients in understanding how CRP&SAA POCT can aid in their diagnosis and treatment. The control arm will not receive any intervention except the usual care. The primary outcome is the proportion of patients of all age groups who are diagnosed with ARIs and prescribed antibiotics during their initial visit in both study arms. All analyses will be conducted using the intention-to-treat approach.
Our study is one of the first trials utilizing CRP&SAA POCT to address the inappropriate prescription of antibiotics for ARIs in village clinics in China. We will also evaluate the implementation process to inform future scale-up in similar resource constrained settings.
ClinicalTrials.gov Identifier - NCT06568432.
抗菌药物耐药性是全球公认的公共卫生威胁。在中国农村地区，急性呼吸道感染（ARI）时使用抗生素很常见，ARI包括咳嗽和发烧等症状，这些症状很可能是病毒感染，但有一小部分是细菌感染。本研究旨在评估基于C反应蛋白和血清淀粉样蛋白A即时检验（CRP&SAA POCT）的综合干预措施在减少中国乡村诊所ARI患者抗生素不合理使用方面的有效性。
这是一项务实的、平行组、对照、整群随机、优效性试验，采用盲法结局评估和数据分析，治疗不设盲。本研究将在中国湖北的40家乡村诊所进行，为期6个月。干预组的20家乡村诊所将实施CRP&SAA POCT。这将包括对乡村医生进行CRP&SAA POCT操作的额外培训，包括集中培训、发放培训手册和桌面提醒。将提供患者教育材料，以帮助患者了解CRP&SAA POCT如何有助于他们的诊断和治疗。对照组除常规护理外不接受任何干预。主要结局是两个研究组中所有年龄组在首次就诊时被诊断为ARI并开具抗生素处方的患者比例。所有分析将采用意向性分析方法。
我们的研究是首批利用CRP&SAA POCT解决中国乡村诊所ARI抗生素不合理处方问题的试验之一。我们还将评估实施过程，为未来在类似资源受限环境中的推广提供参考。
ClinicalTrials.gov标识符 - NCT06568432。
