NCT07130253尚未招募不适用
Efficacy of Vonoprazan-based Rescue Therapy for H. Pylori Eradication
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Eradication rate by intention-to-treat analysis
研究概览
简要总结
- This study aims to compare the efficacy of empirical vonoprazan-based therapy versus susceptibility-guided vonoprazan-based therapy for third-line eradication of H. pylori.
- We also plan to explore the impact of eradication therapy on gut microbiota, fecal antibiotic resistance, and metabolic parameters before and after treatment.
详细描述
Methods:
- Study design: Open-labeled, randomized controlled trial
- Participants: A total of 220 patients who have failed at least two previous H. pylori eradication treatments will be enrolled.
Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics.
Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Empirical vonoprazan-based therapy or (B) Susceptibility-guided vonoprazan-based therapy
Outcome Measurement:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Helicobacter pylori infected individuals who have failed at least two previous eradication therapies.
- •Willing to undergo third-line eradication therapy.
- •Subjects must be 20 years of age or older.
排除标准
- •History of gastrectomy.
- •Individuals unsuitable for the study medication, such as those with a history of allergy or severe adverse reactions to the study drugs, quinolone or fluoroquinolone antibiotics, or women who are pregnant or breastfeeding.
- •Presence of severe acute or chronic diseases such as renal failure, liver cirrhosis, incurable malignant tumors, or a history of aortic aneurysm or dissection.
- •Patients with chronic hepatitis (AST or ALT > 100 U/L).
- •Unwillingness to comply with the treatment plan or sign the informed consent form.
研究组 & 干预措施
Empirical vonoprazan-based therapy
Experimental
干预措施: Vonoprazan based ET (Drug)
Susceptibility-guided vonoprazan-based therapy
Active Comparator
干预措施: Vonoprazan based SGT (Drug)
结局指标
主要结局
Eradication rate by intention-to-treat analysis
时间窗: 6-8 weeks
Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment.
次要结局
- Eradication rate by per-protocol analysis and Frequency of adverse effects.(6-8 weeks)
研究者
研究点 (1)
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