Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Treatment Effectiveness

Treatments: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT06162949

0306381

Details and patient eligibility

About

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).

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 2 patient groups

Vonoprazan-based triple therapy

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Amoxicillin

Drug: Vonoprazan

Proton pump-based triple therapy "standard triple therapy"

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole

Drug: Clarithromycin

Drug: Amoxicillin