Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection
Overview
- Phase
- Phase 4
- Intervention
- empirical therapy
- Conditions
- Self Efficacy
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- Eradication rate after third line rescue therapy
- Last Updated
- 8 years ago
Overview
Brief Summary
We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.
Detailed Description
The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).
Investigators
National Taiwan University Hospital
Doctor
National Taiwan University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.
Exclusion Criteria
- •Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.
Arms & Interventions
Empirical therapy
selection of antibiotic according to medication history
Intervention: empirical therapy
Genotypic resistance guided therapy
selection of antibiotics according to genotypic resistance
Intervention: Genotypic resistance guided therapy
Outcomes
Primary Outcomes
Eradication rate after third line rescue therapy
Time Frame: 8 weeks
Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses. (genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status
Secondary Outcomes
- eradication rates in subgroup analysis by antibiotic resistance and regimen(8 weeks)