drugset / Trial / NCT05874544

Rescue Therapy for Helicobacter Pylori Infection

NCT05874544

Phase 4 Completed 360 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.

Timeline

Start
2023-05-16
Primary completion
2025-01-31
Completion
2025-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1000 mg
Comparator Bismuth Potassium Citrate Unknown 110 mg
Comparator Metronidazole Small molecule 400 mg
Subject Rifabutin Small molecule 150 mg
Comparator Tetracycline Unknown 500 mg
Background Vonoprazan Other / unclassified 20 mg