Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01725906
First received: October 31, 2012
Last updated: June 25, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Taiwan University Hospital, Doctor
ClinicalTrials.gov Identifier: NCT01725906     History of Changes
Other Study ID Numbers: 201202068MIC
Study First Received: October 31, 2012
Last Updated: June 25, 2013
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 01, 2014