Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

May 4, 2017 updated by: National Taiwan University Hospital

Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan Universtiy Hospital
        • Contact:
        • Principal Investigator:
          • Ming-Shiang Wu, MD
      • Yun-Lin County, Taiwan
        • Recruiting
        • National Taiwan University Hospital, Yun-Lin branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Empirical therapy
selection of antibiotic according to medication history
Drug: empirical therapy
  1. Nexium (esomeprazole), 40mg, bid, 14 days, plus
  2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
  3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
  4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
Other Names:
  • selection of antibiotics according to medication history
Experimental: Genotypic resistance guided therapy
selection of antibiotics according to genotypic resistance
Drug: Genotypic resistance guided therapy
  1. Nexium (esomeprazole), 40mg, bid, 14 days, plus
  2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
  3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
  4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
Other Names:
  • selection of antibiotic according to genotypic resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eradication rates in subgroup analysis by antibiotic resistance and regimen
Time Frame: 8 weeks
eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Jyh-Ming Liou, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201202068MIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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