<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/NCT03832465</url>
  </required_header>
  <id_info>
    <org_study_id>18MMHIS168</org_study_id>
    <nct_id>NCT03832465</nct_id>
  </id_info>
  <brief_title>Intraluminal Mono-antibiotic Therapy for Helicobacter Pylori Infection - A Comparison of Levofloxacin Powder and Levofloxacin Solution</brief_title>
  <official_title>Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mackay Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</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) is an important causal factor of chronic gastritis, peptic&#xD;
      ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified&#xD;
      H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the&#xD;
      above diagnosis for patient with H. pylori infection. The eradication of H. pylori can reduce&#xD;
      the recurrence rate of peptic ulcer disease and even has the potential to prevent gastric&#xD;
      cancer. H. pylori is the most common chronic bacterial infection in humans. The prevalence of&#xD;
      H. pylori is about 30-50% in the Western adult population. It is estimated that about 50% of&#xD;
      people are infected with this bacterium in Taiwan.&#xD;
&#xD;
      Triple therapy which contains a proton pump inhibitor and two antibiotics among&#xD;
      clarithromycin, amoxicillin, and metronidazole is the most commonly used regimen for H.&#xD;
      pylori eradication. The treatment duration is 7 to 14 days. However, the eradication rate of&#xD;
      standard triple therapy has fallen below 80% in many countries due to the worldwide&#xD;
      increasing prevalence of antibiotic resistant strains.&#xD;
&#xD;
      Several strategies have been proposed to increase the eradication rate in the first line&#xD;
      therapy or as a rescue therapy, including extending the treatment duration to 14 days,&#xD;
      increasing the doses of antibiotics, the use of four or even five drugs regimen (sequential,&#xD;
      concomitant, quadruple or quintuple therapy), and other antibiotics such as levofloxacin.&#xD;
      However, these therapies may increase the side effects and costs of treatment, decrease the&#xD;
      compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The&#xD;
      WHO has listed H. Pylori as one of 16 antibiotic-resistant bacteria that have the greatest&#xD;
      threat to human health in February, 2017.&#xD;
&#xD;
      The most commonly used oral antibiotics for the treatment of H. pylori are&#xD;
      Amoxicillin、Clarithromycin、Metronidazole、Levofloxacin and Tetracycline.&#xD;
&#xD;
      However, with the increasing rates of antibiotic-resistance for Clarithromycin and&#xD;
      Metronidazole, the Clarithromycin and Metronidazole were replaced by Levofloxacin as a first&#xD;
      line or second line treatment in some area. However, the eradication rate of&#xD;
      Levofloxacin-containing triple therapy is suboptimal in many countries. The investigators aim&#xD;
      to compare the efficacy of different formulation between Levofloxacin Powder and Levofloxacin&#xD;
      Solution in the Intraluminal levofloxacin therapy, and to improve the eradication efficacy of&#xD;
      one-week Levofloxacin-containing triple therapy via the Intraluminal therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg&#xD;
      (5mg/1ml/amp), the vital signs will be closely monitored by physiological monitor (PHILIPS&#xD;
      SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected&#xD;
      or if patient asks for termination. Patients will receive tests to evaluate H. pylori&#xD;
      colonization in the gastric cardia (UFT300) and duodenal bulb (CLO). With endoscope&#xD;
      apparatus, the gastric mucus is irrigated with acetylcysteine solution and the pH value of&#xD;
      gastric juice will be measured with the pH test strips before irrigation and after&#xD;
      irrigation.&#xD;
&#xD;
      The investigators randomly assigned medicaments containing different formulation (powder or&#xD;
      solution ) of levofloxacin to dispense on the surface of gastric mucosa and duodenal mucosa&#xD;
      of duodenal bulb. After the intraluminal therapy, patients will rest for 30 to 60 minutes and&#xD;
      go home if the effect of sedation subsided. Patients can take meal if no abdominal&#xD;
      discomfort. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6&#xD;
      weeks after the intraluminal therapy. Patients failed to achieve intraluminal eradication of&#xD;
      H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy&#xD;
      (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice&#xD;
      daily). The C13-UBT will be used to assess the existence of H. pylori 6 weeks after the oral&#xD;
      antibiotic therapy. The overall eradication rates of the intraluminal therapy plus the oral&#xD;
      antibiotics therapies will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2019</start_date>
  <completion_date type="Actual">December 27, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>
    <intervention_model_description>50 participants are randomly assigned to receive intraluminal eradication of H. pylori.&#xD;
with medicaments containing levofloxacin powder or levofloxacin solution. Patients failed to achieve intraluminal eradication of H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eradication rate of the intraluminal Levofloxacin therapy</measure>
    <time_frame>C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy.</time_frame>
    <description>A Comparison of different formulation between Levofloxacin Powder and Levofloxacin solution</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse effects of the intraluminal Levofloxacin therapy</measure>
    <time_frame>within 7 days after finishing the intraluminal therapies</time_frame>
    <description>A Comparison of different formulation between Levofloxacin Powder and Levofloxacin solution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eradication rates of 7-day or 14-day levofloxacin-containing triple therapy</measure>
    <time_frame>C13-UBT will be used to assess the existence of H. pylori 6 weeks after the levofloxacin-containing triple herapies.</time_frame>
    <description>A Comparison of the eradication rates of 7-day or 14-day levofloxacin-containing triple therapy after intraluminal therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The overall eradication rate</measure>
    <time_frame>3-6 months after finishing the intraluminal therapy</time_frame>
    <description>The overall eradication rates of the intraluminal therapy plus oral antibiotics therapies were evaluated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>Intraluminal Levofloxacin powder therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A Crashed powder of film-coated Levofloxacin Tablet (1 gm) for the Intraluminal therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intraluminal Levofloxacin solution therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B Intravenous solution of Levofloxacin (1 gm) for the Intraluminal therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin film-coated tablet</intervention_name>
    <description>50 participants are randomly assigned to receive intraluminal eradication of H. pylori.&#xD;
with medicaments containing levofloxacin powder or levofloxacin solution.</description>
    <arm_group_label>Intraluminal Levofloxacin powder therapy</arm_group_label>
    <other_name>Leflodal film-coated tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin intravenous solution</intervention_name>
    <description>50 participants are randomly assigned to receive intraluminal eradication of H. pylori.&#xD;
with medicaments containing levofloxacin powder or levofloxacin solution.</description>
    <arm_group_label>Intraluminal Levofloxacin solution therapy</arm_group_label>
    <other_name>Cravit intravenous solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged between 20 years and 75 years&#xD;
&#xD;
          2. Patients have H. pylori infection and have not treated with oral antibiotics&#xD;
&#xD;
          3. Patients are willing to receive the intraluminal therapy. The written informed&#xD;
             consents will be obtained from all patients prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children and teenagers aged less than 20 years or adult greater than 75 years&#xD;
&#xD;
          2. Contraindication for endoscopic examination or food retention in the gastric lumen.&#xD;
&#xD;
          3. History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction;&#xD;
             Gastroduodenal malignancy, including adenocarcinoma and lymphoma&#xD;
&#xD;
          4. Contraindication to treatment drugs: previous allergic reaction to Proton pump&#xD;
             inhibitors, Amoxicillin, Levofloxacin, Acetylcystein, and pregnant or lactating women&#xD;
&#xD;
          5. Severe concurrent acute or chronic illness: renal failure, decompensated cirrhosis of&#xD;
             liver, incurable malignant disease&#xD;
&#xD;
          6. Patients who cannot give informed consent by himself or herself.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tai-cherng Liou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan</name>
      <address>
        <city>Taipei</city>
        <zip>10449</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2021</last_update_submitted>
  <last_update_submitted_qc>February 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mackay Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Tai-cherng Liou, MD</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Levofloxacin</keyword>
  <keyword>Amoxicillin</keyword>
  <keyword>Proton pump inhibitor</keyword>
  <keyword>Helicobacter Pylori</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Helicobacter Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levofloxacin</mesh_term>
    <mesh_term>Ofloxacin</mesh_term>
    <mesh_term>Pharmaceutical Solutions</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/NCT03832465
org study id: 18MMHIS168
nct id: NCT03832465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Helicobacter pylori (H. pylori) is an important causal factor of chronic gastritis, peptic
      ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified
      H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the
      above diagnosis for patient with H. pylori infection. The eradication of H. pylori can reduce
      the recurrence rate of peptic ulcer disease and even has the potential to prevent gastric
      cancer. H. pylori is the most common chronic bacterial infection in humans. The prevalence of
      H. pylori is about 30-50% in the Western adult population. It is estimated that about 50% of
      people are infected with this bacterium in Taiwan.

      Triple therapy which contains a proton pump inhibitor and two antibiotics among
      clarithromycin, amoxicillin, and metronidazole is the most commonly used regimen for H.
      pylori eradication. The treatment duration is 7 to 14 days. However, the eradication rate of
      standard triple therapy has fallen below 80% in many countries due to the worldwide
      increasing prevalence of antibiotic resistant strains.

      Several strategies have been proposed to increase the eradication rate in the first line
      therapy or as a rescue therapy, including extending the treatment duration to 14 days,
      increasing the doses of antibiotics, the use of four or even five drugs regimen (sequential,
      concomitant, quadruple or quintuple therapy), and other antibiotics such as levofloxacin.
      However, these therapies may increase the side effects and costs of treatment, decrease the
      compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The
      WHO has listed H. Pylori as one of 16 antibiotic-resistant bacteria that have the greatest
      threat to human health in February, 2017.

      The most commonly used oral antibiotics for the treatment of H. pylori are
      Amoxicillin、Clarithromycin、Metronidazole、Levofloxacin and Tetracycline.

      However, with the increasing rates of antibiotic-resistance for Clarithromycin and
      Metronidazole, the Clarithromycin and Metronidazole were replaced by Levofloxacin as a first
      line or second line treatment in some area. However, the eradication rate of
      Levofloxacin-containing triple therapy is suboptimal in many countries. The investigators aim
      to compare the efficacy of different formulation between Levofloxacin Powder and Levofloxacin
      Solution in the Intraluminal levofloxacin therapy, and to improve the eradication efficacy of
      one-week Levofloxacin-containing triple therapy via the Intraluminal therapy.
During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg
      (5mg/1ml/amp), the vital signs will be closely monitored by physiological monitor (PHILIPS
      SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected
      or if patient asks for termination. Patients will receive tests to evaluate H. pylori
      colonization in the gastric cardia (UFT300) and duodenal bulb (CLO). With endoscope
      apparatus, the gastric mucus is irrigated with acetylcysteine solution and the pH value of
      gastric juice will be measured with the pH test strips before irrigation and after
      irrigation.

      The investigators randomly assigned medicaments containing different formulation (powder or
      solution ) of levofloxacin to dispense on the surface of gastric mucosa and duodenal mucosa
      of duodenal bulb. After the intraluminal therapy, patients will rest for 30 to 60 minutes and
      go home if the effect of sedation subsided. Patients can take meal if no abdominal
      discomfort. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6
      weeks after the intraluminal therapy. Patients failed to achieve intraluminal eradication of
      H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy
      (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice
      daily). The C13-UBT will be used to assess the existence of H. pylori 6 weeks after the oral
      antibiotic therapy. The overall eradication rates of the intraluminal therapy plus the oral
      antibiotics therapies will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing levofloxacin powder or levofloxacin solution. Patients failed to achieve intraluminal eradication of H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily).
primary purpose: Treatment
masking: None (Open Label)
measure: Eradication rate of the intraluminal Levofloxacin therapy
time frame: C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy.
description: A Comparison of different formulation between Levofloxacin Powder and Levofloxacin solution
measure: Incidence of adverse effects of the intraluminal Levofloxacin therapy
time frame: within 7 days after finishing the intraluminal therapies
description: A Comparison of different formulation between Levofloxacin Powder and Levofloxacin solution
measure: Eradication rates of 7-day or 14-day levofloxacin-containing triple therapy
time frame: C13-UBT will be used to assess the existence of H. pylori 6 weeks after the levofloxacin-containing triple herapies.
description: A Comparison of the eradication rates of 7-day or 14-day levofloxacin-containing triple therapy after intraluminal therapy
measure: The overall eradication rate
time frame: 3-6 months after finishing the intraluminal therapy
description: The overall eradication rates of the intraluminal therapy plus oral antibiotics therapies were evaluated.
arm group label: Intraluminal Levofloxacin powder therapy
arm group type: Experimental
description: Group A Crashed powder of film-coated Levofloxacin Tablet (1 gm) for the Intraluminal therapy
arm group label: Intraluminal Levofloxacin solution therapy
arm group type: Active Comparator
description: Group B Intravenous solution of Levofloxacin (1 gm) for the Intraluminal therapy
intervention type: Drug
intervention name: Levofloxacin film-coated tablet
description: 50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing levofloxacin powder or levofloxacin solution.
arm group label: Intraluminal Levofloxacin powder therapy
other name: Leflodal film-coated tablet
intervention type: Drug
intervention name: Levofloxacin intravenous solution
description: 50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing levofloxacin powder or levofloxacin solution.
arm group label: Intraluminal Levofloxacin solution therapy
other name: Cravit intravenous solution
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tai-cherng Liou, MD
role: Principal Investigator
affiliation: Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Mackay Memorial Hospital
investigator full name: Tai-cherng Liou, MD
investigator title: Principle investigator
mesh term: Infections
mesh term: Helicobacter Infections
mesh term: Levofloxacin
mesh term: Ofloxacin
mesh term: Pharmaceutical Solutions