xml: <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/NCT06030219</url>
    </required_header>
    <id_info>
      <org_study_id>G0505124</org_study_id>
      <nct_id>NCT06030219</nct_id>
    </id_info>
    <brief_title>Microbiome Effect of Omadacycline on Healthy Volunteers</brief_title>
    <official_title>Microbiome Effect of Omadacycline on Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Paratek Pharmaceuticals Inc</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Houston</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to assess microbiome changes associated with omadacycline vs.&#xD;
        comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy&#xD;
        volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days&#xD;
        1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin&#xD;
        125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and&#xD;
        at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool&#xD;
        and used for qPCR biomass and microbial metagenomic experiments. Results from the study will&#xD;
        provide definitive data on the microbiome effects of omadacycline versus comparator&#xD;
        antibiotics.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 12, 2020</start_date>
    <completion_date type="Actual">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">September 1, 2023</primary_completion_date>
    <phase>Phase 1</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>Basic Science</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Microbiome changes</measure>
      <time_frame>During dosing and 30 day follow up period</time_frame>
      <description>Metagenomic changes (16S rRNA) and qPCR for individual bacterial species</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">32</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Omadacycline</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive 3 tablets on day 1 and day 2 (450 mg) followed by 2 tablets (300 mg) for days 3 through 10.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vancomycin (oral)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Moxifloxacin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Omadacycline</intervention_name>
      <description>10-day course</description>
      <arm_group_label>Omadacycline</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vancomycin Pill</intervention_name>
      <description>10-day course</description>
      <arm_group_label>Vancomycin (oral)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Moxifloxacin</intervention_name>
      <description>10-day course</description>
      <arm_group_label>Moxifloxacin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          All volunteers will be considered healthy based on medical history, none will have a&#xD;
          history of cardiovascular, gastrointestinal, hepatic, or renal disease. Subjects will not&#xD;
          have taken an antibiotic for at least three months prior to enrollment. Patients will not&#xD;
          have taken a probiotic for at least a month prior to enrollment and during the entire study&#xD;
          period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kevin W Garey</last_name>
      <role>Principal Investigator</role>
      <affiliation>Professor and Chair</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77204</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Houston</investigator_affiliation>
      <investigator_full_name>Kevin W. Garey</investigator_full_name>
      <investigator_title>Professor and Chair</investigator_title>
    </responsible_party>
    <keyword>omadacycline</keyword>
    <keyword>microbiome</keyword>
    <keyword>healthy volunteer</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Moxifloxacin</mesh_term>
      <mesh_term>Vancomycin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Metagenomic and metadata will be shared by posting to relevant biorepositories or upon reasonable requests from external investigators.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 30, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT06030219/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030219
  org study id: G0505124
  nct id: NCT06030219
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this study is to assess microbiome changes associated with omadacycline vs.
        comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy
        volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days
        1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin
        125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and
        at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool
        and used for qPCR biomass and microbial metagenomic experiments. Results from the study will
        provide definitive data on the microbiome effects of omadacycline versus comparator
        antibiotics.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Single (Outcomes Assessor)
  measure: Microbiome changes
  time frame: During dosing and 30 day follow up period
  description: Metagenomic changes (16S rRNA) and qPCR for individual bacterial species
  arm group label: Omadacycline
  arm group type: Experimental
  description: Subjects will receive 3 tablets on day 1 and day 2 (450 mg) followed by 2 tablets (300 mg) for days 3 through 10.
  arm group label: Vancomycin (oral)
  arm group type: Active Comparator
  description: Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days.
  arm group label: Moxifloxacin
  arm group type: Active Comparator
  description: Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days.
  intervention type: Drug
  intervention name: Omadacycline
  description: 10-day course
  arm group label: Omadacycline
  intervention type: Drug
  intervention name: Vancomycin Pill
  description: 10-day course
  arm group label: Vancomycin (oral)
  intervention type: Drug
  intervention name: Moxifloxacin
  description: 10-day course
  arm group label: Moxifloxacin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kevin W Garey
  role: Principal Investigator
  affiliation: Professor and Chair
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Houston
  investigator full name: Kevin W. Garey
  investigator title: Professor and Chair
  mesh term: Moxifloxacin
  mesh term: Vancomycin
  sharing ipd: Yes
  ipd description: Metagenomic and metadata will be shared by posting to relevant biorepositories or upon reasonable requests from external investigators.
  provided document: 