Department of Gastroenterology, Liaocheng People's Hospital, No. 67 DongchangXi Road, Liaocheng, Shandong Province, China.
Trials. 2023 Jun 19;24(1):413. doi: 10.1186/s13063-023-07457-z.
New treatment strategies are required against infections caused by Helicobacter pylori, which grows increasingly resistant to antibiotics. Polymerase chain reaction-based methods for antibiotic susceptibility testing are available for detecting H. pylori-specific mutations that confer resistance to clarithromycin and levofloxacin. Several meta-analyses have compared eradication rates for susceptibility-guided versus empirical therapy for H. pylori treatment; however, all have significant limitations and high heterogeneity, and the results are contradictory. The main objective of this trial is to assess whether a sequential strategy based on molecular susceptibility testing-guided therapy for H. pylori has a better eradication rate than empirical therapy.
This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. Men and women who are H. pylori-positive, naïve to treatment, and aged 18-65 years will be recruited. A total of 500 participants will be randomised to receive either empirical therapy or a susceptibility-guided sequential strategy. Bismuth quadruple therapy will be the empirical first-line therapy, and in case of failure, high-dose dual (proton-pump inhibitor + amoxicillin) treatment will be the rescue therapy. For the susceptibility-guided sequential strategy, regimen selection will be based on H. pylori susceptibility to clarithromycin (first-line) and levofloxacin (rescue). A first-line treatment of clarithromycin triple therapy will be selected for clarithromycin-sensitive strains. For clarithromycin resistance, a high-dose dual therapy will be selected. During the rescue treatment, a levofloxacin quadruple regimen will be selected for levofloxacin-sensitive strains, and a furazolidone quadruple regimen will be selected for others. The primary outcome is the first-line eradication rate in both groups, and the overall (including first and rescue therapies) H. pylori eradication rate in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis, and per-protocol analysis.
This randomised controlled trial will provide objective and valid evidence about the value of polymerase chain reaction-based molecular methods for antibiotic susceptibility testing in guiding H. pylori eradication.
Clinicaltrials.gov NCT05549115. Released on 18 September 2022. First posted on 22 September 2022. Enrolment of the first participant on 20 September 2022. The study is retrospectively registered.
需要新的治疗策略来对抗日益对抗生素产生耐药性的幽门螺杆菌感染。基于聚合酶链反应的抗生素药敏检测方法可用于检测导致克拉霉素和左氧氟沙星耐药的幽门螺杆菌特异性突变。几项荟萃分析比较了药敏指导与经验治疗对幽门螺杆菌治疗的根除率；然而，所有这些都存在显著的局限性和高度异质性，结果相互矛盾。本试验的主要目的是评估基于分子药敏检测指导的幽门螺杆菌治疗的序贯策略是否比经验治疗具有更高的根除率。
本试验设计为前瞻性、随机、开放标签、活性对照和单中心研究。招募未经治疗且对治疗无经验的 H. pylori 阳性的男性和女性，年龄在 18-65 岁之间。总共将招募 500 名参与者，随机分为接受经验治疗或药敏指导序贯策略。铋四联疗法将作为经验一线治疗，如果失败，高剂量双联（质子泵抑制剂+阿莫西林）治疗将作为挽救治疗。对于药敏指导序贯策略，方案选择将基于 H. pylori 对克拉霉素（一线）和左氧氟沙星（挽救）的药敏性。对于克拉霉素敏感株，将选择克拉霉素三联一线治疗。对于克拉霉素耐药，将选择高剂量双联治疗。在挽救治疗中，对于左氧氟沙星敏感株，将选择左氧氟沙星四联方案，对于其他株，将选择呋喃唑酮四联方案。主要结局是两组的一线根除率，两组的总体（包括一线和挽救治疗）幽门螺杆菌根除率是次要结局之一。将通过意向治疗分析、修改意向治疗分析和方案分析分析 H. pylori 的根除率。
本随机对照试验将提供基于聚合酶链反应的分子药敏检测方法指导幽门螺杆菌根除的价值的客观和有效证据。
Clinicaltrials.gov NCT05549115。2022 年 9 月 18 日发布。2022 年 9 月 22 日首次发布。2022 年 9 月 20 日招募第一名参与者。该研究为回顾性注册。
