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Recruiting NCT06959368

Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

Phase IV Interventional Helicobacter Pylori Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg.
Who it may be relevant to
Registry conditions: Helicobacter Pylori Infection. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg
    Participants will receive the respective drug regimens twice daily. The Vonoprazan triple therapy arm will administer Vonoprazan 20 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily. The Standard triple therapy arm will administer Esomeprazole 40 mg, Amoxicillin 1 g, and Clarithromycin 500 mg twice daily.

Primary outcome measures

  • 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 [Time frame: 1 year]
Secondary outcome measures (1)
  • Assessment of adverse events and eradication rates in antibiotic-resistant strains. [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • AIG hospitals — Hyderabad

Identifiers

NCT: NCT06959368 · VECTOR-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗