Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication

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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Vonoprazan 20mg, Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 484
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Krithi Krishna Koduri Doctor; Phone Number: +91 9870083545; Email: drkrithivk@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • AIG Hospitals
      • Contact: AIG hospitals; Phone Number: 040 4244 4222; Email: info@aighospitals.com
      • Principal Investigator: Koduri Krithi Krishna, MBBS, MD, DNB
      • Principal Investigator: Aniruddha Pratap Singh, MBBS, MD, DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vonoprazan triple therapy; • Vonoprazan Triple Therapy: Vonoprazan 20 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).	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.
Active Comparator: Standard triple therapy; • Standard Triple Therapy: Esomeprazole 40 mg, Amoxicillin 1 g, Clarithromycin 500 mg (all twice daily).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The primary outcome measurement is to assess the eradication of H. pylori i.e. negative UBT or stool antigen test 4 weeks after treatment	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of adverse events and eradication rates in antibiotic-resistant strains.	Assessment of adverse events and eradication rates in antibiotic-resistant strains.	1 year

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): March 25, 2026
• Study Completion (Estimated): March 25, 2026

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Amoxicillin; Clarithromycin; Esomeprazole
• Other Study ID Numbers: VECTOR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No