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临床试验/NCT06959368
NCT06959368招募中4 期

A Randomised Controlled Trial Comparing Vonoprazan Triple Therapy (Vonoprazan, Amoxicillin, Clarithromycin), and Standard Triple Therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter Pylori Eradication in Indian Population. VECTOR Trial - Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 484 人开始时间: 2025年3月25日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
484
试验地点
1
主要终点
A randomised controlled trial comparing Vonoprazan triple therapy (Vonoprazan, Amoxicillin, Clarithromycin), and standard triple therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter pylori eradication in Indian population. VECTOR trial

研究概览

简要总结

Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Based on the clinical and microbiological data it is now well known to be the strongest risk factor for developing intestinal type and diffuse type of adenocarcinoma(2-4). While testing and treating asymptomatic persons is a grey area, it is now recommended to rule out H. pylori in un-investigated dyspepsia patients (5-7), and if detected, it must be treated. However, worldwide and especially in the Asian countries, we face a widespread problem of antibiotic resistance(8,9). Regimens are typically selected based on the varying regional clarithromycin resistance(6,9). There is a need for an efficient and reliable empirical therapy that can be universal, has maximal eradication rates irrespective of resistance patterns, has good compliance and minimal adverse events without the emergence of superbugs. We also need a reliable rescue therapy for H. pylori eradication failure.

详细描述

Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Based on the clinical and microbiological data it is now well known to be the strongest risk factor for developing intestinal type and diffuse type of adenocarcinoma(2-4). While testing and treating asymptomatic persons is a grey area, it is now recommended to rule out H. pylori in un-investigated dyspepsia patients (5-7), and if detected, it must be treated. However, worldwide and especially in the Asian countries, we face a widespread problem of antibiotic resistance(8,9). Regimens are typically selected based on the varying regional clarithromycin resistance(6,9). There is a need for an efficient and reliable empirical therapy that can be universal, has maximal eradication rates irrespective of resistance patterns, has good compliance and minimal adverse events without the emergence of superbugs. We also need a reliable rescue therapy for H. pylori eradication failure.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (18 years - 80 years)
  • Patient visiting clinic with dyspepsia, GERD, or non-bleeding peptic ulcer
  • 13C-urea breath test (UBT) positive/ Rapid urease test positive (RUT) on endoscopic biopsy
  • Off PPIs for 2 weeks

排除标准

  • Penicillin allergy
  • Recent use of antibiotics in the past 1 month
  • Previous H. pylori therapy
  • Intestinal metaplasia, gastric cancer, bleeding peptic ulcer
  • Patient who is unable to understand study protocol or not consenting
  • Pregnancy, lactation
  • Patient on anticoagulation, NSAIDs
  • Patient using drugs with interactions with vonoprazan, amoxicillin, clarithromycin or PPIs
  • Cirrhosis, Chronic kidney disease, chronic lung disease

研究组 & 干预措施

Vonoprazan triple therapy

Active Comparator

• Vonoprazan Triple Therapy: Vonoprazan 20 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).

干预措施: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (Drug)

Standard triple therapy

Active Comparator

• Standard Triple Therapy: Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).

干预措施: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (Drug)

结局指标

主要结局

A randomised controlled trial comparing Vonoprazan triple therapy (Vonoprazan, Amoxicillin, Clarithromycin), and standard triple therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter pylori eradication in Indian population. VECTOR trial

时间窗: 1 year

The primary outcome measurement is to assess the eradication of H. pylori i.e. negative UBT or stool antigen test 4 weeks after treatment

次要结局

  • Assessment of adverse events and eradication rates in antibiotic-resistant strains.(1 year)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Sponsor

研究点 (1)

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