Vonoprazan for Helicobacter Pylori Eradication in Adolescents (VONTAPE)

Vonoprazan-based Triple Therapy vs. Standard Triple Therapy for Helicobacter Pylori Eradication in Adolescents: A Randomized, Double-blinded Controlled Trial

The trial tends to evaluate the efficacy of vonoprazan-based triple therapy in eradicating H. Pylori infection in adolescent patients in Egypt, in comparison to standard treatment regimens to determine if it offers superior eradication rates (VONTAPE trial).

Study Overview

• Status: Recruiting
• Conditions: Treatment Effectiveness
• Intervention / Treatment: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Esomeprazole

Detailed Description

The VONTAPE trial will compare two treatment regimens for Helicobacter pylori eradication among adolescent patients presented to the gastroenterology department in an Egyptian institute. the eligible subjects will be randomly assigned to one of the two protocols (vonoprazan based vs. proton pump inhibitor-based triple therapy) for two weeks. then the eradication rates will be compared between the two study groups to see if there is a difference in efficacy.

The currently available eradication regimens in our country show a low to intermediate eradication rate (50-75%). At the same time, H. pylori infection is prevalent.

Recently, the FDA approved vonoprazan-based regimens for adult H. pylori infection with high eradication rates even in the settings of clarithromycin antibiotic resistance.

In the VOTSAPE trial, we will test this efficacy in the < 18 years adolescents.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sameh A Lashen, MD; Phone Number: +20 1274117543; Email: sameh.lashen@alexmed.edu.eg
• Study Contact Backup: Name: Engy S Elkaragy, MD; Email: engy.saad@alexmed.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Recruiting
    • Faculty of medicine
    • Contact: Sameh A Lashen, MD(PhD); Phone Number: 01274117543; Email: sameh.lashen@alexmed.edu.eg
    • Contact: Engy S Elkaragy, MD(PhD); Phone Number: +201223193191; Email: engy.saad@alexmed.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Children in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain.
2. Who is positive for H. Pylori infection by a standardized diagnostic test.
3. Pediatric patients with a clinical, laboratory, and endoscopic diagnosis of H.P.-positive gastritis and the other conditions necessary for H.P. eradication according to the Maastricht V consensus report.

Exclusion Criteria:

1. allergy to any of the drugs used in the study
2. previous attempts to eradicate H.P.
3. Use of antibiotics, acid-suppression, bismuth, or probiotics 4 weeks before enrollment.
4. Children with conditions that affect medication absorption e.g. celiac or Crohn's disease.
5. Liver or kidney failure.
6. symptoms suggestive of functional disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vonoprazan-based triple therapy; Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g] The triple combination will be given for 14 days	Drug: Vonoprazan; an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.; Other Names: Vonacidan; Tavoniza; Vondalous; Drug: Amoxicillin; An antibiotic of penicillins antibiotic group; Other Names: Emox; Ibiamox; Amoxicid; Drug: Clarithromycin; An antibiotic of macrolide group; Other Names: Klacid; Klarithro; Klarimix; Infectocure
Active Comparator: Proton pump-based triple therapy "standard triple therapy"; Esomeprazole tablets [20 mg/day if < 30 kg and 40 mg/daily if ≥ 30 kg] on two divided daily doses plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g] The triple combination will be given for 14 days	Drug: Amoxicillin; An antibiotic of penicillins antibiotic group; Other Names: Emox; Ibiamox; Amoxicid; Drug: Clarithromycin; An antibiotic of macrolide group; Other Names: Klacid; Klarithro; Klarimix; Infectocure; Drug: Esomeprazole; An acid suppressor therapy that blocks the proton pump.; Other Names: Nexium; Neximash; Esomium; Nexicure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter Pylori eradication rate	Number of patients who will test negative for H. pylori after treatment completion.	4 weeks after completion of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The adverse events during therapy	Treatment-related adverse effects (TRAEs) such as abdominal discomfort, diarrhea, vomiting, nausea, flatulence, taste disturbance, or loss of appetite, the need for discontinuation of the H. pylori therapy; and/or headache.	During the treatment duration, and the end of the 2 weeks treatment protocol

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Sameh A Lashen, MD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adolescent; Helicobacter pylori; Vonoprazan; Eradication rate; Standard triple therapy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Amoxicillin; Clarithromycin; Esomeprazole
• Other Study ID Numbers: 0306381

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
• product manufactured in and exported from the U.S.: No