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/NCT06040489</url>
    </required_header>
    <id_info>
      <org_study_id>57768421.0.0000.5558</org_study_id>
      <nct_id>NCT06040489</nct_id>
    </id_info>
    <brief_title>Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly</brief_title>
    <official_title>Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Brasilia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Brasilia</source>
    <oversight_info>
      <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>
        Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to&#xD;
        intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 22, 2022</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>Phase 2/Phase 3</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>Cure</measure>
      <time_frame>90 days after the begin of treatment</time_frame>
      <description>Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse effects</measure>
      <time_frame>30 days after drug interruption</time_frame>
      <description>Presence laboratorial or clinica changes during treatment that lead to treatment interruption</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Leishmaniasis; Brazilian</condition>
    <condition>Leishmaniasis, Mucocutaneous</condition>
    <arm_group>
      <arm_group_label>Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Miltefosine 50mg</intervention_name>
      <description>Oral Miltefosine 50mg bid</description>
      <arm_group_label>Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis</arm_group_label>
      <arm_group_label>Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pentoxifylline 400mg</intervention_name>
      <description>Oral Pentoxifylline 400mg tid</description>
      <arm_group_label>Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis</arm_group_label>
      <arm_group_label>Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Liposomal Amphotericin B</intervention_name>
      <description>Intravenous 25 to 40mg/kg</description>
      <arm_group_label>Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis</arm_group_label>
      <arm_group_label>Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis&#xD;
  &#xD;
            -  Use of highly effective contraceptive method and a negative serologic pregnancy test&#xD;
               (beta - HCG), if female in fertile phase&#xD;
  &#xD;
            -  Agree and sing informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous treatment with leishmanicidal drugs in the last 6 months&#xD;
  &#xD;
            -  Pre-treatment electrocardiographic changes that contraindicate the use of liposomal&#xD;
               amphotericin B (QTc greater than 450ms)&#xD;
  &#xD;
            -  Serum creatinine or urea 1.5 times the upper limit of normal&#xD;
  &#xD;
            -  Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus&#xD;
  &#xD;
            -  history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine&#xD;
               and/or pentoxifylline&#xD;
  &#xD;
            -  Pregnant and breastfeeding women&#xD;
  &#xD;
            -  Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Raimunda Sampaio, PhD</last_name>
      <phone>+556120285415</phone>
      <email>rnrsampaio@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sofia Martins, PhD</last_name>
      <phone>+556120285415</phone>
      <email>sofiasalesm@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Universitario de Brasilia</name>
        <address>
          <city>Brasilia</city>
          <state>DF</state>
          <zip>70840-901</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Raimunda Sampaio, PhD</last_name>
        <phone>+556120285415</phone>
        <email>rnrsampaio@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>November 28, 2022</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Elderly</keyword>
    <keyword>Miltefosine</keyword>
    <keyword>Leishmaniasis</keyword>
    <keyword>Pentoxifylline</keyword>
    <keyword>Liposomal amphotericin b</keyword>
    <keyword>Treatment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leishmaniasis</mesh_term>
      <mesh_term>Leishmaniasis, Mucocutaneous</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Amphotericin B</mesh_term>
      <mesh_term>Liposomal amphotericin B</mesh_term>
      <mesh_term>Miltefosine</mesh_term>
      <mesh_term>Pentoxifylline</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06040489
  org study id: 57768421.0.0000.5558
  nct id: NCT06040489
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to
        intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Cure
  time frame: 90 days after the begin of treatment
  description: Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)
  measure: Adverse effects
  time frame: 30 days after drug interruption
  description: Presence laboratorial or clinica changes during treatment that lead to treatment interruption
  arm group label: Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
  arm group type: Experimental
  arm group label: Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
  arm group type: Experimental
  arm group label: Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis
  arm group type: Active Comparator
  arm group label: Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Miltefosine 50mg
  description: Oral Miltefosine 50mg bid
  arm group label: Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
  arm group label: Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
  intervention type: Drug
  intervention name: Pentoxifylline 400mg
  description: Oral Pentoxifylline 400mg tid
  arm group label: Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
  arm group label: Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
  intervention type: Drug
  intervention name: Liposomal Amphotericin B
  description: Intravenous 25 to 40mg/kg
  arm group label: Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis
  arm group label: Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Raimunda Sampaio, PhD
  phone: +556120285415
  email: rnrsampaio@hotmail.com
  last name: Sofia Martins, PhD
  phone: +556120285415
  email: sofiasalesm@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Sponsor
  mesh term: Leishmaniasis
  mesh term: Leishmaniasis, Mucocutaneous
  mesh term: Amphotericin B
  mesh term: Liposomal amphotericin B
  mesh term: Miltefosine
  mesh term: Pentoxifylline