drugset / Trial / NCT05664685

Optimized Bismuth Quadruple Therapy vs Triple Standard Therapy for Helicobacter Pylori Eradication

NCT05664685 ↗

Phase 4 Completed 127 enrolled Pontificia Universidad Catolica de Chile
RandomizedParallel-groupTriple-blindTreatment

Summary

This study have as primary aim "To compare the H. pylori eradication rate between the quadruple bismuth therapy versus the standard triple therapy recommended by the AUGE Clinical Guidelines for Helicobacter pylori eradication treatment in peptic ulcer patients." Briefly, this is a randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists of omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, which consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days

Timeline

Start
2022-10-17
Primary completion
2023-10-30
Completion
2024-01-30

Outcome

Met primary endpoint

paper significantly higher eradication rate versus standard triple therapy: 95% (60/63) [95% CI 86%-99%] vs. 81% (52/64) [70%-89%], p = 0.033. PMID 41362749 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1 g —
Subject Bismuth subsalicylate Small molecule 369 mg —
Comparator Clarithromycin Small molecule 500 mg —
Subject Esomeprazole Small molecule 40 mg —
Subject Metronidazole Small molecule 500 mg —
Comparator Omeprazole Other / unclassified 20 mg —