Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

Phase 4

• Conditions: Self Efficacy
• Interventions: Drug: empirical therapy; Drug: Genotypic resistance guided therapy

• Registration Number: NCT01725906
• Lead Sponsor: National Taiwan University Hospital

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).

Study Timeline

• Study First Submitted: 2012-10-31
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-14
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empirical therapy	empirical therapy	selection of antibiotic according to medication history
Genotypic resistance guided therapy	Genotypic resistance guided therapy	selection of antibiotics according to genotypic resistance

Primary Outcome Measures

Name	Time	Method
Eradication rate after third line rescue therapy	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 Outcome Measures

Name	Time	Method
eradication rates in subgroup analysis by antibiotic resistance and regimen	8 weeks	eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen

Trial Locations

Locations (2)

National Taiwan Universtiy Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital, Yun-Lin Branch; 🇨🇳 Yun-Lin County, Taiwan