Antimicrobial Resistance-Stratified Efficacy of Vonoprazan, Clarithromycin, and Metronidazole Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Single-Arm Prospective Interventional Study.
- 1Department of Gastroenterology Yokohama City University Graduate School of Medicine Yokohama Japan.
Abstract
Background
Choosing an effective Helicobacter pylori eradication regimen for patients with penicillin allergy remains a clinical challenge. Although vonoprazan-based regimens yield excellent outcomes in standard populations, we still lack sufficient evidence regarding penicillin-allergic patients. To address this gap, we investigated how a 1-week triple therapy (vonoprazan, clarithromycin [CAM], and metronidazole [MNZ]) performs in this specific cohort, particularly considering the influence of antimicrobial resistance.Methods
This exploratory, single-arm, open-label interventional study was conducted at Yokohama City University Hospital (jRCTs031200171). Patients with H. pylori infection and confirmed penicillin allergy were enrolled. The treatment regimen consisted of vonoprazan (20 mg), CAM (200 mg), and MNZ (250 mg), each administered twice daily for 7 days. The primary endpoint was the eradication success rate. Secondary endpoints included safety and the association between eradication success and antimicrobial susceptibility.Results
Thirty patients completed the intervention. The overall eradication rate was 90.0% (27/30; 95% confidence interval [CI], 73.5%-97.9%) in per-protocol and intention-to-treat analyses. Adherence was high (99.7%). According to resistance profiles, eradication rates were 100% (15/15; 95% CI, 78.2%-100%) in CAM-susceptible strains, 78.6% (11/14; 95% CI, 49.2%-95.3%) in CAM-resistant strains, 92.0% (23/25; 95% CI, 74.0%-99.0%) in MNZ-susceptible strains, 75.0% (3/4; 95% CI, 19.4%-99.4%) in MNZ-resistant strains, and 50.0% (1/2) in dual-resistant strains. No serious adverse events were documented.Conclusions
A 1-week triple therapy with vonoprazan, CAM, and MNZ is an effective and safe treatment option for H. pylori eradication in patients with penicillin allergy. While the regimen achieved excellent results in CAM-susceptible strains, further optimization may be required for cases involving dual antibiotic resistance.
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BibTeX
@article{sue2026antimicrobial,
title = {{Antimicrobial Resistance-Stratified Efficacy of Vonoprazan, Clarithromycin, and Metronidazole Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Single-Arm Prospective Interventional Study.}},
author = {Soichiro Sue and Ryosuke Ikeda and Aya Ikeda and Hiroki Sato and Yoshihiro Goda and Hiroaki Kaneko and Kuniyasu Irie and Shin Maeda},
journal = {JGH open : an open access journal of gastroenterology and hepatology},
year = {2026},
month = oct,
doi = {10.1002/jgh3.70487},
url = {https://europepmc.org/article/MED/42909144},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Antimicrobial Resistance-Stratified Efficacy of Vonoprazan, Clarithromycin, and Metronidazole Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Single-Arm Prospective Interventional Study.
AU - Soichiro Sue
AU - Ryosuke Ikeda
AU - Aya Ikeda
AU - Hiroki Sato
AU - Yoshihiro Goda
AU - Hiroaki Kaneko
AU - Kuniyasu Irie
AU - Shin Maeda
PY - 2026
DA - 2026/10/20
JO - JGH open : an open access journal of gastroenterology and hepatology
DO - 10.1002/jgh3.70487
UR - https://europepmc.org/article/MED/42909144
AB - Background Choosing an effective Helicobacter pylori eradication regimen for patients with penicillin allergy remains a clinical challenge. Although vonoprazan-based regimens yield excellent outcomes in standard populations, we still lack sufficient evidence regarding penicillin-allergic patients. To address this gap, we investigated how a 1-week triple therapy (vonoprazan, clarithromycin [CAM], and metronidazole [MNZ]) performs in this specific cohort, particularly considering the influence of antimicrobial resistance.Methods This exploratory, single-arm, open-label interventional study was conducted at Yokohama City University Hospital (jRCTs031200171). Patients with H. pylori infection and confirmed penicillin allergy were enrolled. The treatment regimen consisted of vonoprazan (20 mg), CAM (200 mg), and MNZ (250 mg), each administered twice daily for 7 days. The primary endpoint was the eradication success rate. Secondary endpoints included safety and the association between eradication success and antimicrobial susceptibility.Results Thirty patients completed the intervention. The overall eradication rate was 90.0% (27/30; 95% confidence interval [CI], 73.5%-97.9%) in per-protocol and intention-to-treat analyses. Adherence was high (99.7%). According to resistance profiles, eradication rates were 100% (15/15; 95% CI, 78.2%-100%) in CAM-susceptible strains, 78.6% (11/14; 95% CI, 49.2%-95.3%) in CAM-resistant strains, 92.0% (23/25; 95% CI, 74.0%-99.0%) in MNZ-susceptible strains, 75.0% (3/4; 95% CI, 19.4%-99.4%) in MNZ-resistant strains, and 50.0% (1/2) in dual-resistant strains. No serious adverse events were documented.Conclusions A 1-week triple therapy with vonoprazan, CAM, and MNZ is an effective and safe treatment option for H. pylori eradication in patients with penicillin allergy. While the regimen achieved excellent results in CAM-susceptible strains, further optimization may be required for cases involving dual antibiotic resistance.
SN - 2397-9070
ER -