<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/NCT02988089</url>
  </required_header>
  <id_info>
    <org_study_id>2016SDU-QILU-23</org_study_id>
    <nct_id>NCT02988089</nct_id>
  </id_info>
  <brief_title>Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment</brief_title>
  <official_title>Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Jinan Military Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Binzhou People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaocheng People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been&#xD;
      recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac&#xD;
      gastric cancer. Strongly evidence supports that H. pylori eradication is an effective&#xD;
      approach to reduce the incidence of those pathologies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 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 rates in 2 groups</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the rate of improving dyspepsia symptoms after H. pylori eradication</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of adverse events happening</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of good compliance (take pills more than 90%)</measure>
    <time_frame>5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference of cost per patient for each eradication achieved in 2 groups</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <condition>Antimicrobial Susceptibility Testing</condition>
  <arm_group>
    <arm_group_label>clarithromycin dependant group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.&#xD;
The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin.&#xD;
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 antibiotics dependant group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.&#xD;
Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>salvage therapy for negative culture</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>salvage therapy for failed eradication</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clarithromycin susceptibility dependant strategy</intervention_name>
    <description>Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin.&#xD;
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.</description>
    <arm_group_label>clarithromycin dependant group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )</intervention_name>
    <description>Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.</description>
    <arm_group_label>6 antibiotics dependant group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>proton pump inhibitor (PPI) and Colloidal Bismuth Pectin</intervention_name>
    <description>all patients need these two drugs.</description>
    <arm_group_label>6 antibiotics dependant group</arm_group_label>
    <arm_group_label>clarithromycin dependant group</arm_group_label>
    <arm_group_label>salvage therapy for failed eradication</arm_group_label>
    <arm_group_label>salvage therapy for negative culture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>amoxicillin and clarithromycin or amoxicillin and furazolidone</intervention_name>
    <description>patients in the 6 antibiotics dependant group will use these intervention.</description>
    <arm_group_label>clarithromycin dependant group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>amoxicillin and furazolidone or amoxicillin and tetracycline</intervention_name>
    <description>salvage therapy for negative culture when the results of culture are negative</description>
    <arm_group_label>salvage therapy for negative culture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin</intervention_name>
    <description>salvage therapy for failed eradication if failed with AST guided eradication therapy</description>
    <arm_group_label>salvage therapy for failed eradication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients who are 18-70 years old with persistent H. pylori infection after&#xD;
             first or second line treatment attempts.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enable to undergo upper endoscopy;&#xD;
&#xD;
          -  Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;&#xD;
&#xD;
          -  Known or suspected allergy to study medications;&#xD;
&#xD;
          -  Taking bismuth and antibiotics in the previous four weeks, or taking proton pump&#xD;
             inhibitor and H2-receptor blockers in the previous two weeks;&#xD;
&#xD;
          -  Currently pregnant or lactating&#xD;
&#xD;
          -  Inability to provide informed consent and other situations that could interfere with&#xD;
             the examination or therapeutic protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Yanqing, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital of Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Yanqing, MD, PhD</last_name>
    <phone>86-531-82169236</phone>
    <email>liyanqing@sdu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology, Qilu Hospital, Shandong University</name>
      <address>
        <city>Ji'nan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanqing Li, MD, PhD</last_name>
      <phone>86-531-82169236</phone>
      <email>liyanqing@sdu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yanqing Li, MD, PhD</last_name>
      <phone>86-0531-82169236</phone>
      <email>liyanqing@sdu.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>April 23, 2017</last_update_submitted>
  <last_update_submitted_qc>April 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>Vice president of Qilu Hospital</investigator_title>
  </responsible_party>
  <keyword>Helicobacter Pylori Infection</keyword>
  <keyword>Antimicrobial susceptibility testing (AST)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease Susceptibility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Clarithromycin</mesh_term>
    <mesh_term>Levofloxacin</mesh_term>
    <mesh_term>Ofloxacin</mesh_term>
    <mesh_term>Tetracycline</mesh_term>
    <mesh_term>Tinidazole</mesh_term>
    <mesh_term>Furazolidone</mesh_term>
    <mesh_term>Bismuth</mesh_term>
    <mesh_term>Proton Pump Inhibitors</mesh_term>
  </intervention_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/NCT02988089
org study id: 2016SDU-QILU-23
nct id: NCT02988089
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been
      recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac
      gastric cancer. Strongly evidence supports that H. pylori eradication is an effective
      approach to reduce the incidence of those pathologies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Eradication rates in 2 groups
time frame: 6 months
measure: the rate of improving dyspepsia symptoms after H. pylori eradication
time frame: 6 months
measure: the rate of adverse events happening
time frame: 6 months
measure: the rate of good compliance (take pills more than 90%)
time frame: 5 months
measure: difference of cost per patient for each eradication achieved in 2 groups
time frame: 6 months
arm group label: clarithromycin dependant group
arm group type: Experimental
description: Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.
The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin.
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.
arm group label: 6 antibiotics dependant group
arm group type: Experimental
description: Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.
arm group label: salvage therapy for negative culture
arm group type: Other
description: when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily.
arm group label: salvage therapy for failed eradication
arm group type: Other
description: If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d.
intervention type: Drug
intervention name: Clarithromycin susceptibility dependant strategy
description: Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin.
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.
arm group label: clarithromycin dependant group
intervention type: Drug
intervention name: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )
description: Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
arm group label: 6 antibiotics dependant group
intervention type: Drug
intervention name: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
description: all patients need these two drugs.
arm group label: 6 antibiotics dependant group
arm group label: clarithromycin dependant group
arm group label: salvage therapy for failed eradication
arm group label: salvage therapy for negative culture
intervention type: Drug
intervention name: amoxicillin and clarithromycin or amoxicillin and furazolidone
description: patients in the 6 antibiotics dependant group will use these intervention.
arm group label: clarithromycin dependant group
intervention type: Drug
intervention name: amoxicillin and furazolidone or amoxicillin and tetracycline
description: salvage therapy for negative culture when the results of culture are negative
arm group label: salvage therapy for negative culture
intervention type: Drug
intervention name: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin
description: salvage therapy for failed eradication if failed with AST guided eradication therapy
arm group label: salvage therapy for failed eradication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Li Yanqing, MD, PhD
role: Principal Investigator
affiliation: Qilu Hospital of Shandong University
last name: Li Yanqing, MD, PhD
phone: 86-531-82169236
email: liyanqing@sdu.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Vice president of Qilu Hospital
mesh term: Disease Susceptibility
mesh term: Anti-Bacterial Agents
mesh term: Amoxicillin
mesh term: Metronidazole
mesh term: Clarithromycin
mesh term: Levofloxacin
mesh term: Ofloxacin
mesh term: Tetracycline
mesh term: Tinidazole
mesh term: Furazolidone
mesh term: Bismuth
mesh term: Proton Pump Inhibitors
sharing ipd: No