Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy

Kaohsiung Medical University

Status: Enrolling

Conditions: Helicobacter Pylori Infection

Treatments: Drug: rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole; Drug: vonoprazan, tripotassium dicitrate bismuthate, amoxicilline

Study type: Interventional

Funder types: Other

Identifiers

NCT07358130

KMUHIRB-F(I)-20250254

Details and patient eligibility

About

(1) To compare the efficacy and safety of a 14-day bismuth-amoxicillin-vonoprazan triple therapy versus a 14-day bismuth-based quadruple therapy as first-line treatments for H. pylori infection, and (2) To investigate the influence of H. pylori antibiotic resistance, along with host CYP3A4, CYP2C19, and IL-1B -511 genotypes, on the eradication efficacy of H. pylori therapies.

Full description

This multicenter, randomized, open-label, trial will enroll 552 adult patients with H. pylori infection from 12 medical centers or regional hospitals in Taiwan. Using a computer-generated randomization sequence (1:1 allocation; block size of four), participants will be assigned to receive either the 14-day bismuth-amoxicillin-vonoprazan triple therapy or the 14-day bismuth-rabeprazole-tetracycline-metronidazole quadruple therapy. Follow-up at week 2 will assess treatment adherence and adverse events. H. pylori status will be evaluated at week 6 using the C13-urea breath test. Eradication and adverse event rates will be compared between groups using the chi-square test. The impact of H. pylori antibiotic resistance and host CYP3A4, CYP2C19, and IL-1B -511 genotypes on treatment efficacy will be analyzed using multivariate models.

Enrollment: 552 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Helicobacter pylori infection

Exclusion criteria

1. Subjects with known hypersensitivity to the study drug.
2. Subjects with a history of gastric surgery.
3. Subjects with severe liver cirrhosis or uremia.
4. Subjects with a history of malignancy within the past five years.
5. Pregnant or breastfeeding women.
6. Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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552 participants in 2 patient groups

bismuth-amoxicillin-vonoprazan triple therapy

Active Comparator group

Description:

vonoprazan 20mg twice a day +tripotassium dicitrate bismuthate 300mg four times a day +amoxicilline 750mg four times a day

Treatment:

Drug: rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole

bismuth-based quadruple therapy

Active Comparator group

Description:

rabeprazole 20mg twice a day+ tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ metronidazole 250mg four times a day

Treatment:

Drug: vonoprazan, tripotassium dicitrate bismuthate, amoxicilline