Cui Yi, Zhang Shenke, Hu Shuqin, Fei Sujuan, Yang Geliang
Department of Gastroenterology, The Third People's Hospital of Zhengzhou, Zhengzhou, Henan, China.
Marshall Laboratory of Biomedical Engineering, School of Biomedical Engineering, Shenzhen University Medical School, Shenzhen University, Shenzhen, Guangdong, China.
BMJ Open. 2024 Dec 20;14(12):e088788. doi: 10.1136/bmjopen-2024-088788.
is a major health problem, with the high prevalence of and the increasing antibiotic resistance rate in China. Antibiotic resistance is the main reason for the failure of eradication. This study aims to evaluate the efficacy and safety of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR (qPCR) for eradication.
This is a multicentre, open, randomised clinical trial that will enroll 324 patients with infection. Patients will be randomised to two groups for a 14-day treatment: Treatment group will be treated with proton pump inhibitor (PPI), bismuth with two different kinds of antibiotics susceptibly guided by string test coupled with qPCR, while control group will be treated empirically with PPI, bismuth with two different kinds of antibiotics. The types and dosages of bismuth, PPI and antibiotics administered in this trial are based on the 2022 Chinese Guidelines for the treatment of infection and the Sixth Chinese National Consensus Report on the management of infection. The primary endpoint is the eradication rate, while secondary endpoints include compliance, the incidence of adverse events and adverse drug reactions.
This study was approved by the ethics committee of the Third People's Hospital of Zhengzhou (No. 2024-04-001-K02). The results will be published in the appropriate peer-reviewed journal.
ChiCTR2400082768.
在中国，[具体疾病名称]是一个重大的健康问题，其患病率高且抗生素耐药率不断上升。抗生素耐药是[疾病名称]根除失败的主要原因。本研究旨在评估采用串珠试验联合定量聚合酶链反应（qPCR）进行药敏指导的四联疗法根除[疾病名称]的疗效和安全性。
这是一项多中心、开放、随机临床试验，将纳入324例[疾病名称]感染患者。患者将被随机分为两组，进行为期14天的治疗：治疗组将接受质子泵抑制剂（PPI）、铋剂联合两种根据串珠试验联合qPCR药敏指导的抗生素治疗，而对照组将接受经验性的PPI、铋剂联合两种抗生素治疗。本试验中使用的铋剂、PPI和抗生素的类型及剂量基于《2022年中国[疾病名称]感染治疗指南》和《中国[疾病名称]感染管理第六次全国共识报告》。主要终点是根除率，次要终点包括依从性、不良事件和药物不良反应的发生率。
本研究已获得郑州市第三人民医院伦理委员会批准（编号：2024 - 04 - 001 - K02）。研究结果将发表在合适的同行评审期刊上。
ChiCTR2400082768。
