<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01725906</url>
  </required_header>
  <id_info>
    <org_study_id>201202068MIC</org_study_id>
    <nct_id>NCT01725906</nct_id>
  </id_info>
  <brief_title>Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication</brief_title>
  <official_title>Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs.&#xD;
      empiric therapy in the third line therapy. Factors affecting the eradication rates, including&#xD;
      the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to compare the regimens selected using either one of the&#xD;
      method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather&#xD;
      than to compare the efficacy of any drugs).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eradication rate after third line rescue therapy</measure>
    <time_frame>8 weeks</time_frame>
    <description>Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses.&#xD;
(genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>eradication rates in subgroup analysis by antibiotic resistance and regimen</measure>
    <time_frame>8 weeks</time_frame>
    <description>eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Self Efficacy</condition>
  <arm_group>
    <arm_group_label>Empirical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>selection of antibiotic according to medication history</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genotypic resistance guided therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>selection of antibiotics according to genotypic resistance</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>empirical therapy</intervention_name>
    <description>Nexium (esomeprazole), 40mg, bid, 14 days, plus&#xD;
Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus&#xD;
Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs&#xD;
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</description>
    <arm_group_label>Empirical therapy</arm_group_label>
    <other_name>selection of antibiotics according to medication history</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genotypic resistance guided therapy</intervention_name>
    <description>Nexium (esomeprazole), 40mg, bid, 14 days, plus&#xD;
Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus&#xD;
Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs&#xD;
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</description>
    <arm_group_label>Genotypic resistance guided therapy</arm_group_label>
    <other_name>selection of antibiotic according to genotypic resistance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged greater than 20 years who have persistent H. pylori infection after at&#xD;
             least two treatments and are willing to receive third line rescue regimens are&#xD;
             considered eligible for enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from the study if any one of the following criteria is&#xD;
             present: (1) children and teenagers aged less than 20 years, (2) history of&#xD;
             gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4)&#xD;
             previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt&#xD;
             pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant&#xD;
             or lactating women, (7) severe concurrent disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jyh-Ming Liou</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jyh-Ming Liou, MD</last_name>
    <phone>+886223123456</phone>
    <phone_ext>63541</phone_ext>
    <email>dtmed046@pchome.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan Universtiy Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jyh-Ming Liou, MD</last_name>
      <phone>+886972651883</phone>
      <email>dtmed046@pchome.com.tw</email>
    </contact>
    <investigator>
      <last_name>Ming-Shiang Wu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital, Yun-Lin Branch</name>
      <address>
        <city>Yun-Lin County</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Chieh-Chang Chen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>May 4, 2017</last_update_submitted>
  <last_update_submitted_qc>May 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>National Taiwan University Hospital</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>genotypic resistance guided therapy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Antibiotics, Antitubercular</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01725906
org study id: 201202068MIC
nct id: NCT01725906
lead sponsor: 
collaborator: 
has dmc: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Eradication rate after third line rescue therapy
time frame: 8 weeks
description: 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
measure: eradication rates in subgroup analysis by antibiotic resistance and regimen
time frame: 8 weeks
description: eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen
arm group label: Empirical therapy
arm group type: Active Comparator
description: selection of antibiotic according to medication history
arm group label: Genotypic resistance guided therapy
arm group type: Experimental
description: selection of antibiotics according to genotypic resistance
intervention type: Drug
intervention name: empirical therapy
description: Nexium (esomeprazole), 40mg, bid, 14 days, plus
Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
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
arm group label: Empirical therapy
other name: selection of antibiotics according to medication history
intervention type: Drug
intervention name: Genotypic resistance guided therapy
description: Nexium (esomeprazole), 40mg, bid, 14 days, plus
Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
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
arm group label: Genotypic resistance guided therapy
other name: selection of antibiotic according to genotypic resistance
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jyh-Ming Liou
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Jyh-Ming Liou, MD
phone: +886223123456
phone ext: 63541
email: dtmed046@pchome.com.tw
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: National Taiwan University Hospital
investigator title: Doctor
mesh term: Anti-Bacterial Agents
mesh term: Antibiotics, Antitubercular