<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/NCT04462133</url>
  </required_header>
  <id_info>
    <org_study_id>XC20ENDT0022</org_study_id>
    <nct_id>NCT04462133</nct_id>
  </id_info>
  <brief_title>Optimal Tailored Treatment for H. Pylori Infection</brief_title>
  <official_title>Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incheon St.Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incheon St.Mary's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The efficacy of the current standard triple therapy is at an unacceptably low level.&#xD;
      Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard&#xD;
      triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of&#xD;
      clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a&#xD;
      dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was&#xD;
      introduced and made commercially available. The primary goal of our study was to compare the&#xD;
      eradication rates of empirical therapy and tailored therapy. Specifically we examined the&#xD;
      eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our&#xD;
      secondary goal was to examine the adverse events of each treatment, cost effectiveness of&#xD;
      each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are randomly assigned to the empirical therapy group and tailored therapy group.&#xD;
&#xD;
      The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy&#xD;
      group receives treatment based on their DPO-PCR results.&#xD;
&#xD;
      Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7&#xD;
      or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth&#xD;
      quadruple therapy for 7 or 14 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Empirical treatment versus tailored therapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eradication success</measure>
    <time_frame>8-12 weeks after eradication</time_frame>
    <description>H. pylori eradication success based on urea breath test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1988</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <condition>Antibiotic Resistant Infection</condition>
  <arm_group>
    <arm_group_label>Empirical therapy for H. pylori infection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tailored therapy for H. pylori infection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)</intervention_name>
    <description>Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results</description>
    <arm_group_label>Empirical therapy for H. pylori infection</arm_group_label>
    <arm_group_label>Tailored therapy for H. pylori infection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consecutive subjects who underwent upper gastrointestinal endoscopy and who had a&#xD;
             confirmed diagnosis of H pylori infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects younger than 18 years old&#xD;
&#xD;
          -  subjects with a history of H pylori eradication&#xD;
&#xD;
          -  subjects who had previous gastric surgery&#xD;
&#xD;
          -  subjects who were pregnant or lactating&#xD;
&#xD;
          -  subjects with serious concurrent illness&#xD;
&#xD;
          -  subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding&#xD;
             the study&#xD;
&#xD;
          -  subjects with a history of allergy to any one of the compounds in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byung-Wook Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Incheon St.Mary's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Byung-Wook Kim, MD, PhD</last_name>
    <phone>82-32-280-5057</phone>
    <email>gastro@catholic.ac.kr</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 4, 2020</last_update_submitted>
  <last_update_submitted_qc>July 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Incheon St.Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Joon Sung Kim</investigator_full_name>
    <investigator_title>Assistant Proffessor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04462133
org study id: XC20ENDT0022
nct id: NCT04462133
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The efficacy of the current standard triple therapy is at an unacceptably low level.
      Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard
      triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of
      clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a
      dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was
      introduced and made commercially available. The primary goal of our study was to compare the
      eradication rates of empirical therapy and tailored therapy. Specifically we examined the
      eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our
      secondary goal was to examine the adverse events of each treatment, cost effectiveness of
      each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.
Patients are randomly assigned to the empirical therapy group and tailored therapy group.

      The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy
      group receives treatment based on their DPO-PCR results.

      Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7
      or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth
      quadruple therapy for 7 or 14 days.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Empirical treatment versus tailored therapy
primary purpose: Treatment
masking: None (Open Label)
measure: Eradication success
time frame: 8-12 weeks after eradication
description: H. pylori eradication success based on urea breath test
arm group label: Empirical therapy for H. pylori infection
arm group type: Active Comparator
description: The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication
arm group label: Tailored therapy for H. pylori infection
arm group type: Experimental
description: The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR.
intervention type: Diagnostic Test
intervention name: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
description: Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results
arm group label: Empirical therapy for H. pylori infection
arm group label: Tailored therapy for H. pylori infection
criteria: 
gender: All
minimum age: 19 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Byung-Wook Kim, MD, PhD
role: Principal Investigator
affiliation: Incheon St.Mary's Hospital
last name: Byung-Wook Kim, MD, PhD
phone: 82-32-280-5057
email: gastro@catholic.ac.kr
responsible party type: Principal Investigator
investigator affiliation: Incheon St.Mary's Hospital
investigator full name: Joon Sung Kim
investigator title: Assistant Proffessor
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: No