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Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection
Sponsor: National Taiwan University Hospital
Summary
Aim: Therefore, we aimed to 1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection 2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors. Methods: This will be a multi-center, open labeled trial Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics. Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy Outcome Measurement: Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses. Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.
Official title: Comparison of Susceptibility Testing Guided Versus Empirical Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial
Key Details
Gender
All
Age Range
20 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2020-07-28
Completion Date
2026-12
Last Updated
2025-08-29
Healthy Volunteers
No
Conditions
Interventions
ET
Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple/quadruple therapy or concomitant therapy
SGT
Susceptibility testing guided therapy Based on susceptibility test: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple/quadruple therapy or concomitant therapy
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan