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/NCT05967130</url>
    </required_header>
    <id_info>
      <org_study_id>SBMU-</org_study_id>
      <nct_id>NCT05967130</nct_id>
    </id_info>
    <brief_title>Treatment Chronic UTI Post Kidney Transplant</brief_title>
    <official_title>Treatment of Chronic Relapsing Urinary Tract Infection With Bacteriophages in Renal Transplant Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shahid Beheshti University of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shahid Beheshti University of Medical Sciences</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Urinary tract infections (UTIs) with extended-spectrum -lactamase (ESBL)-positive&#xD;
        Enterobacteriums (ESBL-E) are a common infectious complication of renal transplant&#xD;
        recipients, with 10% of patients suffering from UTIs with ESBL-E within the first year&#xD;
        posttransplant. Moreover, recurrence rates of UTI caused by ESBL-E are almost three times&#xD;
        higher than those by cephalosporin-susceptible Enterobacteriums demonstrating the decreased&#xD;
        efficacy of antibiotics in the treatment of these UTIs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        According to each patient's urine culture, resistant urinary tract infections will be treated&#xD;
        with specific phages and patients will be followed up with their urine cultures for response&#xD;
        to therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Urine culture</measure>
      <time_frame>1 week after administration</time_frame>
      <description>Negative Urine Culture</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Urinary Tract Infections</condition>
    <condition>Transplant-Related Disorder</condition>
    <arm_group>
      <arm_group_label>UC Positives</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Stable Transplanted Patients with Positive UC</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Phage</intervention_name>
      <description>Inserting specific specimen of phages in to the bladder</description>
      <arm_group_label>UC Positives</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stable Kidney Transplant Recipients&#xD;
  &#xD;
            -  Stable Immunosupression Dose&#xD;
  &#xD;
            -  Stable Renal Function&#xD;
  &#xD;
            -  Resistant Urinary Infection with Positive UC&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Rejection periods&#xD;
  &#xD;
            -  Frail Patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dalili</last_name>
      <role>Principal Investigator</role>
      <affiliation>SBMU</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dalili</last_name>
      <phone>00989122404331</phone>
      <phone_ext>0098</phone_ext>
      <email>dr.nooshindalili@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nooshin Dalili</name>
        <address>
          <city>Tehran</city>
          <zip>1666663421</zip>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nooshin Dalili, Dr</last_name>
        <phone>00989122404331</phone>
        <email>nooshindalili4@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
      <investigator_full_name>nooshin dalili</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Urinary Tract Infections</mesh_term>
    </condition_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/NCT05967130
  org study id: SBMU-
  nct id: NCT05967130
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Urinary tract infections (UTIs) with extended-spectrum -lactamase (ESBL)-positive
        Enterobacteriums (ESBL-E) are a common infectious complication of renal transplant
        recipients, with 10% of patients suffering from UTIs with ESBL-E within the first year
        posttransplant. Moreover, recurrence rates of UTI caused by ESBL-E are almost three times
        higher than those by cephalosporin-susceptible Enterobacteriums demonstrating the decreased
        efficacy of antibiotics in the treatment of these UTIs.
  According to each patient's urine culture, resistant urinary tract infections will be treated
        with specific phages and patients will be followed up with their urine cultures for response
        to therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Urine culture
  time frame: 1 week after administration
  description: Negative Urine Culture
  arm group label: UC Positives
  arm group type: Experimental
  description: Stable Transplanted Patients with Positive UC
  intervention type: Biological
  intervention name: Phage
  description: Inserting specific specimen of phages in to the bladder
  arm group label: UC Positives
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Dalili
  role: Principal Investigator
  affiliation: SBMU
  last name: Dalili
  phone: 00989122404331
  phone ext: 0098
  email: dr.nooshindalili@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Shahid Beheshti University of Medical Sciences
  investigator full name: nooshin dalili
  investigator title: Assistant Professor
  mesh term: Infections
  mesh term: Urinary Tract Infections
  sharing ipd: No