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Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

This study is currently recruiting participants.
Verified May 2017 by National Taiwan University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725906
First Posted: November 14, 2012
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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.

Condition Intervention Phase
Self Efficacy Drug: empirical therapy Drug: Genotypic resistance guided therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 450
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: selection of antibiotic according to genotypic resistance

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725906


Contacts
Contact: Jyh-Ming Liou, MD +886223123456 ext 63541 dtmed046@pchome.com.tw

Locations
Taiwan
National Taiwan Universtiy Hospital Recruiting
Taipei, Taiwan
Contact: Jyh-Ming Liou, MD    +886972651883    dtmed046@pchome.com.tw   
Principal Investigator: Ming-Shiang Wu, MD         
National Taiwan University Hospital, Yun-Lin Branch Recruiting
Yun-Lin County, Taiwan
Principal Investigator: Chieh-Chang Chen, MD         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Jyh-Ming Liou National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital, Doctor
ClinicalTrials.gov Identifier: NCT01725906     History of Changes
Other Study ID Numbers: 201202068MIC
First Submitted: October 31, 2012
First Posted: November 14, 2012
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by National Taiwan University Hospital:
genotypic resistance guided therapy

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents