drugset / Trial / NCT05332444

Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection

NCT05332444

Phase 4 Recruiting 450 enrolled National Taiwan University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The prevalence of H. pylori antibiotic resistance has reached an alarming level worldwide. Antibiotic stewardship programs should be urgently developed and implemented. However, H. pylori antimicrobial susceptibility testing (AST) is rarely offered, making local resistance patterns not easily available. Guideline-recommended empiric therapies (GR-ET) may no longer reliably achieve high cure rate in the era of increasing antibiotic resistance. susceptibility-guided tailored therapy (SG-TT) may be a good choice to solve this problem. The aims of this study are: 1. to compare the efficacy of SG-TT with GR-ET as rescue regimens for H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Timeline

Start
2022-04-11
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 500 mg
Subject Amoxicillin Other / unclassified 750 mg
Subject Amoxicillin Other / unclassified 1000 mg
Comparator Bismuth Potassium Citrate Unknown 120 mg
Subject Clarithromycin Small molecule 500 mg
Subject Levofloxacin Small molecule 500 mg
Subject Metronidazole Small molecule 250 mg
Subject Metronidazole Small molecule 500 mg
Subject Rabeprazole Small molecule 20 mg
Comparator Tetracycline Unknown 500 mg