Efficacy of Vonoprazan Versus Proton Pump Inhibitors in Combination With Antibiotics as a Triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Assessment the fecal H.Pylori Ag after receiving Vonoprazan in combination with antibiotics as a triple therapy in patients with Clarithromycin-resistant strain of H.Pylori infection.
研究概览
简要总结
The goal of this Randomized controlled trial is to assessment Efficacy of Vonoprazan versus Proton Pump Inhibitors in Combination with Antibiotics as a triple Therapy for Eradication of Clarithromycin Resistant Strain of Helicobacter Pylori (H. pylori).
This randomized controlled study was performed on 2 groups of Egyptian patients diagnosed with dyspepsia; group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days and group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days. All patients of the two groups were followed up for persistence of infection 8 weeks after the end of treatment by testing fecal H. pylori antigen (Ag).
详细描述
This randomized controlled trial included two groups of Egyptian patients diagnosed with dyspepsia related to Clarithromycin-resistant strains of H.pylori.
- Group (1) included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for two weeks.
- Group (2) included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days.
The included cases were collected from gastroenterology outpatient clinic and inpatient department at Ain shams University hospital between October 2023 and April 2024.
The work had been conducted after the scientific ethics committee approval and after obtaining an informed consent from all the included cases.
All cases were diagnosed with H. Pylori resistant infection after clarithromycin based treatment regimen for H. pylori confirmed with persistent positive test of fecal H. pylori Ag before the starting of the study.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with dyspepsia related to Clarithromycin-resistant strains of H.pylori. All cases were diagnosed with H. Pylori resistant infection after clarithromycin based treatment regimen for H. pylori confirmed with persistent positive test of fecal H. pylori Ag before the starting of the study.
- •Must be able to swallow tablets.
排除标准
- •Cases with drug allergy from drugs included in the study.
- •those having inflammatory-bowel diseases.
- •those with malabsorption syndrome.
- •those having gastroenterology malignancy.
- •patients on immunotherapy.
- •HIV patients.
研究组 & 干预措施
Vonoprazan Group
included 160 patients received Vonoprazan 20 mg oral once daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for two weeks.
干预措施: Vonoprazan, Amoxicillin and Levofloxacin (Drug)
Pantoprazole Group
included 160 patients received Pantoprazole 40 mg oral twice daily + Levofloxacin 500 mg oral once daily + Amoxicillin 1 gm oral twice daily for 14 days
干预措施: Pantoprazole 40mg, Amoxicillin and Levofloxacin (Drug)
结局指标
主要结局
Assessment the fecal H.Pylori Ag after receiving Vonoprazan in combination with antibiotics as a triple therapy in patients with Clarithromycin-resistant strain of H.Pylori infection.
时间窗: All patients of the two groups were followed up for 2 months.
comparison between the efficiency of Vonoprazan and Pantoprazole in eradication of Clarithromycin-resistant strain of H.Pylori.
次要结局
未报告次要终点