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/NCT05980871</url>
    </required_header>
    <id_info>
      <org_study_id>202206138MIND</org_study_id>
      <nct_id>NCT05980871</nct_id>
    </id_info>
    <brief_title>Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline</brief_title>
    <official_title>Treatment Responses of Early Syphilis to Single-dose Ceftriaxone Plus Doxycycline Versus Single-dose Benzathine Penicillin G Plus Doxycycline in PLWH</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In a prospective study investigating the prevalence of STIs among at-risk PLWH, the&#xD;
        prevalence of Chlamydia trachomatis and N. gonorrhoeae was 24.7% and 12.1%, respectively.&#xD;
        Surprisingly, the study found high rates of C. trachomatis and/or N. gonorrhoeae&#xD;
        co-infections in PLWH with recent hepatitis C virus (HCV) infection (50%), HBsAg positivity&#xD;
        (44%), and early syphilis (36%). Considering the high rate of sexually transmitted&#xD;
        co-infections, combination therapy of single-dose ceftriaxone plus 7-day doxycycline for&#xD;
        early syphilis may provide convenience and benefit to treatment of N. gonorrhoeae and C.&#xD;
        trachomatis co-infections at a single clinic encounter. In the present study, this study aim&#xD;
        to compare the efficacy of ceftriaxone plus doxycycline versus BPG plus doxycycline as the&#xD;
        treatment for early syphilis among PLWH.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Enrolled criteria:&#xD;
  &#xD;
          1. PLWH aged 20 years or more&#xD;
  &#xD;
          2. PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed&#xD;
             by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum&#xD;
             particle agglutination (TPPA) assay.&#xD;
  &#xD;
          3. PLWH has provided informed consent *A participant with repeated syphilis can be repeated&#xD;
             enrolled after signing an informed consent if the previous episode of early syphilis was&#xD;
             successfully treated with achieving at least a 4-fold decrease in RPR titers and 48-week&#xD;
             follow-up is completed.&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
          1. PLWH with RPR titers of less than 4&#xD;
  &#xD;
          2. Exposure to antibiotics with activity against T. pallidum, such as penicillins,&#xD;
             third-generation cephems, doxycycline, or macrolides, within the preceding 4 weeks&#xD;
  &#xD;
          3. A known or suspected infection other than syphilis requiring additional treatment with&#xD;
             an antimicrobial active against T. pallidum&#xD;
  &#xD;
          4. A history of intolerance to penicillin, ceftriaxone, or doxycycline&#xD;
  &#xD;
          5. Pregnancy&#xD;
  &#xD;
        Primary outcome:&#xD;
  &#xD;
        Serologic response at month 6 (defined as either a 4-fold or greater decline in RPR titer&#xD;
        compared to baseline or being RPR-nonreactive)&#xD;
  &#xD;
        Secondary outcomes:&#xD;
  &#xD;
          1. Microbiologic response of syphilis (defined as T. pallidum PCR Ct value &gt;38) at week 4&#xD;
  &#xD;
          2. Microbiologic response of bacterial STIs (defined as negative PCR results) at week 4&#xD;
  &#xD;
          3. Serologic response at months 3 and 12&#xD;
  &#xD;
          4. Safety of study treatment recorded by using a diary (all adverse events will be coded&#xD;
             and graded according to Common Terminology Criteria for Adverse Events [CTCAE] v4.0.)&#xD;
  &#xD;
          5. Adherence evaluation (the noting of tablet intake in the diary for the 7 days of the&#xD;
             treatment period)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 10, 2023</start_date>
    <completion_date type="Anticipated">March 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 15, 2025</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>Rate of serologic response at month 6</measure>
      <time_frame>Month 6</time_frame>
      <description>Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of microbiologic response of syphilis at week 4</measure>
      <time_frame>Week 4</time_frame>
      <description>Microbiologic response of syphilis is defined as T. pallidum PCR Ct value &gt;38</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of microbiologic response of bacterial STIs at week 4</measure>
      <time_frame>Week 4</time_frame>
      <description>Microbiologic response of bacterial STIs is defined as negative PCR results</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of serologic response at months 3 and 12</measure>
      <time_frame>Months 3 and 12</time_frame>
      <description>Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Early Syphilis</condition>
    <arm_group>
      <arm_group_label>single-dose ceftriaxone plus doxycycline</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>single-dose BPG plus doxycycline</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>single-dose BPG (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Doxycycline</intervention_name>
      <description>doxycycline (100 mg orally twice daily for 7 days)</description>
      <arm_group_label>single-dose BPG plus doxycycline</arm_group_label>
      <arm_group_label>single-dose ceftriaxone plus doxycycline</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ceftriaxone</intervention_name>
      <description>Ceftriaxone (1g intramuscularly once)</description>
      <arm_group_label>single-dose ceftriaxone plus doxycycline</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>benzathine penicillin G</intervention_name>
      <description>benzathine penicillin G (2.4 MU intramuscularly once)</description>
      <arm_group_label>single-dose BPG plus doxycycline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  PLWH aged 20 years or more&#xD;
  &#xD;
            -  PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis),&#xD;
               confirmed by a positive rapid plasma reagin (RPR) titer with a reactive Treponema&#xD;
               pallidum particle agglutination (TPPA) assay.&#xD;
  &#xD;
            -  PLWH has provided informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  PLWH with RPR titers of less than 4&#xD;
  &#xD;
            -  Exposure to antibiotics with activity against T. pallidum, such as penicillins, third-&#xD;
               generation cephems, doxycycline, or macrolides, within the preceding 4 weeks&#xD;
  &#xD;
            -  A known or suspected infection other than syphilis requiring additional treatment with&#xD;
               an antimicrobial active against T. pallidum&#xD;
  &#xD;
            -  A history of intolerance to penicillin, ceftriaxone, or doxycycline&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kuan-Yin Lin</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kuan-Yin Lin</last_name>
      <phone>+886975607715</phone>
      <email>kuanyin0828@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kuan-Yin Lin</name>
        <address>
          <city>Taipei</city>
          <zip>110</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kuan-Yin Lin</last_name>
        <phone>+886975607715</phone>
        <email>maregold@ntuh.gov.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syphilis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Doxycycline</mesh_term>
      <mesh_term>Ceftriaxone</mesh_term>
      <mesh_term>Penicillins</mesh_term>
      <mesh_term>Penicillin G</mesh_term>
      <mesh_term>Penicillin G Benzathine</mesh_term>
      <mesh_term>Penicillin G Procaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05980871
  org study id: 202206138MIND
  nct id: NCT05980871
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  In a prospective study investigating the prevalence of STIs among at-risk PLWH, the
        prevalence of Chlamydia trachomatis and N. gonorrhoeae was 24.7% and 12.1%, respectively.
        Surprisingly, the study found high rates of C. trachomatis and/or N. gonorrhoeae
        co-infections in PLWH with recent hepatitis C virus (HCV) infection (50%), HBsAg positivity
        (44%), and early syphilis (36%). Considering the high rate of sexually transmitted
        co-infections, combination therapy of single-dose ceftriaxone plus 7-day doxycycline for
        early syphilis may provide convenience and benefit to treatment of N. gonorrhoeae and C.
        trachomatis co-infections at a single clinic encounter. In the present study, this study aim
        to compare the efficacy of ceftriaxone plus doxycycline versus BPG plus doxycycline as the
        treatment for early syphilis among PLWH.
  Enrolled criteria:
  
          1. PLWH aged 20 years or more
  
          2. PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed
             by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum
             particle agglutination (TPPA) assay.
  
          3. PLWH has provided informed consent *A participant with repeated syphilis can be repeated
             enrolled after signing an informed consent if the previous episode of early syphilis was
             successfully treated with achieving at least a 4-fold decrease in RPR titers and 48-week
             follow-up is completed.
  
        Exclusion criteria:
  
          1. PLWH with RPR titers of less than 4
  
          2. Exposure to antibiotics with activity against T. pallidum, such as penicillins,
             third-generation cephems, doxycycline, or macrolides, within the preceding 4 weeks
  
          3. A known or suspected infection other than syphilis requiring additional treatment with
             an antimicrobial active against T. pallidum
  
          4. A history of intolerance to penicillin, ceftriaxone, or doxycycline
  
          5. Pregnancy
  
        Primary outcome:
  
        Serologic response at month 6 (defined as either a 4-fold or greater decline in RPR titer
        compared to baseline or being RPR-nonreactive)
  
        Secondary outcomes:
  
          1. Microbiologic response of syphilis (defined as T. pallidum PCR Ct value >38) at week 4
  
          2. Microbiologic response of bacterial STIs (defined as negative PCR results) at week 4
  
          3. Serologic response at months 3 and 12
  
          4. Safety of study treatment recorded by using a diary (all adverse events will be coded
             and graded according to Common Terminology Criteria for Adverse Events [CTCAE] v4.0.)
  
          5. Adherence evaluation (the noting of tablet intake in the diary for the 7 days of the
             treatment period)
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of serologic response at month 6
  time frame: Month 6
  description: Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
  measure: Rate of microbiologic response of syphilis at week 4
  time frame: Week 4
  description: Microbiologic response of syphilis is defined as T. pallidum PCR Ct value >38
  measure: Rate of microbiologic response of bacterial STIs at week 4
  time frame: Week 4
  description: Microbiologic response of bacterial STIs is defined as negative PCR results
  measure: Rate of serologic response at months 3 and 12
  time frame: Months 3 and 12
  description: Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
  arm group label: single-dose ceftriaxone plus doxycycline
  arm group type: Active Comparator
  description: single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
  arm group label: single-dose BPG plus doxycycline
  arm group type: Active Comparator
  description: single-dose BPG (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
  intervention type: Drug
  intervention name: Doxycycline
  description: doxycycline (100 mg orally twice daily for 7 days)
  arm group label: single-dose BPG plus doxycycline
  arm group label: single-dose ceftriaxone plus doxycycline
  intervention type: Drug
  intervention name: Ceftriaxone
  description: Ceftriaxone (1g intramuscularly once)
  arm group label: single-dose ceftriaxone plus doxycycline
  intervention type: Drug
  intervention name: benzathine penicillin G
  description: benzathine penicillin G (2.4 MU intramuscularly once)
  arm group label: single-dose BPG plus doxycycline
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kuan-Yin Lin
  role: Principal Investigator
  affiliation: National Taiwan University Hospital
  last name: Kuan-Yin Lin
  phone: +886975607715
  email: kuanyin0828@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Syphilis
  mesh term: Doxycycline
  mesh term: Ceftriaxone
  mesh term: Penicillins
  mesh term: Penicillin G
  mesh term: Penicillin G Benzathine
  mesh term: Penicillin G Procaine
  sharing ipd: No