<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/NCT03819712</url>
  </required_header>
  <id_info>
    <org_study_id>18-PP-05</org_study_id>
    <nct_id>NCT03819712</nct_id>
  </id_info>
  <brief_title>Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections</brief_title>
  <acronym>Predict-UTI</acronym>
  <official_title>Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Urinary tract infections affect more than 130 million people worldwide each year. Almost 50%&#xD;
      of women will have at least one urinary tract infection during their lifetime, usually&#xD;
      cystitis. Half of them will have recurrent cystitis. Antibiotics are the first-line treatment&#xD;
      for cystitis, but their effectiveness is decreasing due to the rapid spread of&#xD;
      multi-resistant uro-pathogenic bacteria. The objective of this study is to identify blood&#xD;
      biomarkers associated with a high risk of recurrent cystitis. Immune system cells, and more&#xD;
      specifically innate immunity cells, play a key role in controlling urinary tract infections.&#xD;
      In addition, clinical studies have shown that there is a high inter-individual variability in&#xD;
      the ability of innate immune cells to respond to different stimuli. We therefore hypothesized&#xD;
      that there was an association between the risk of recurrent cystitis and a deficiency of&#xD;
      certain immune cell types in producing certain pro-inflammatory cytokines, including TNF-α,&#xD;
      in response to one or more bacterial stimuli, particularly flagellin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 28, 2019</start_date>
  <completion_date type="Anticipated">July 27, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 27, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TNF-α measurement in blood cell culture media using Luminex® technology.</measure>
    <time_frame>At 18 months</time_frame>
    <description>The concentrations of TNF-α will be expressed in ng/ml by calibration with a standard range.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Urinary Tract Infections</condition>
  <arm_group>
    <arm_group_label>No recurrent UTI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recurrent UTI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Collection of blood samples</intervention_name>
    <description>23 mL of blood will be collected during the inclusion visit</description>
    <arm_group_label>No recurrent UTI</arm_group_label>
    <arm_group_label>Recurrent UTI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of fecal samples</intervention_name>
    <description>Fecal sample self-collected after the inclusion visit</description>
    <arm_group_label>No recurrent UTI</arm_group_label>
    <arm_group_label>Recurrent UTI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of urine samples</intervention_name>
    <description>10 mL of urine will be collected during the inclusion visit</description>
    <arm_group_label>No recurrent UTI</arm_group_label>
    <arm_group_label>Recurrent UTI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of vaginal swaps</intervention_name>
    <description>Sample of vaginal microbiota collected during the inclusion visit</description>
    <arm_group_label>No recurrent UTI</arm_group_label>
    <arm_group_label>Recurrent UTI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged 18 to 28 years;&#xD;
&#xD;
          -  Subject accepting to be serologically tested for HIV and HCV;&#xD;
&#xD;
          -  Subject considered healthy by the physician on the basis of medical history and&#xD;
             clinical examination;&#xD;
&#xD;
          -  Subject with a body mass index between 18.5 and 30 kg/m2;&#xD;
&#xD;
          -  Subject understands and speaks French and is able to give written consent;&#xD;
&#xD;
          -  Subject affiliated to Social Security or a similar regime;&#xD;
&#xD;
          -  Having reported a single cystitis since the age of 14 (Group 1), or 3 or more cystitis&#xD;
             over a 12-month period since the age of 14 (Group 2).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject protected by law under guardianship or curatorship, or unable to participate&#xD;
             in a clinical study under Article L. 1121-16 of the French Public Health Code;&#xD;
&#xD;
          -  Subject who has participated in a clinical research study in the last 3 months in&#xD;
             which he/she was exposed to a pharmaceutical product or medical device;&#xD;
&#xD;
          -  Subject who has stayed in a tropical or subtropical country in the last 3 months;&#xD;
&#xD;
          -  Pregnant or breastfeeding subject for women of childbearing age;&#xD;
&#xD;
          -  Subject with special diet for medical reasons and prescribed by a doctor or dietician&#xD;
             (e.g. a low-calorie diet or a diet intended to lower cholesterol levels);&#xD;
&#xD;
          -  Subject who regularly consumes large quantities of alcohol, i. e. more than 50 g of&#xD;
             pure alcohol per day (e. g. more than 4 glasses of 150 ml wine, more than 4 pints of&#xD;
             250 ml beer, or more than 4 glasses of 40 ml containing strong alcohol);&#xD;
&#xD;
          -  Subject who has used an illegal recreational drug in the past 3 months;&#xD;
&#xD;
          -  Subject who has taken an immunosuppressive or immunomodulatory drug (excluding&#xD;
             intranasally or topically administered corticosteroids) in the past 2 weeks, or for&#xD;
             more than 14 consecutive days in the past 6 months;&#xD;
&#xD;
          -  Subject who has been vaccinated within the last 3 months;&#xD;
&#xD;
          -  Subject who received a blood transfusion or immunoglobulins in the last 3 months;&#xD;
&#xD;
          -  Subject stating that he has not been fasting for at least 10 hours;&#xD;
&#xD;
          -  Subject reporting HIV or HCV status;&#xD;
&#xD;
          -  Subject who had an infectious episode or was treated with antibiotics during the 4&#xD;
             weeks prior to the visit;&#xD;
&#xD;
          -  Subject with a positive urinary pregnancy test;&#xD;
&#xD;
          -  Subject with a severe and/or chronic and/or recurrent pathology, in particular:&#xD;
&#xD;
               -  A chronic inflammatory and/or autoimmune or allergic disease and in particular a&#xD;
                  chronic inflammatory disease of the intestine (Crohn's disease, ulcerative&#xD;
                  colitis), epidermis (psoriasis, atopic dermatitis), joints (rheumatoid&#xD;
                  arthritis), nervous system (multiple sclerosis), type I diabetes;&#xD;
&#xD;
               -  High blood pressure or type II diabetes;&#xD;
&#xD;
               -  A neurodegenerative disease.&#xD;
&#xD;
          -  Subject who has been diagnosed with cancer and has not been in remission for more than&#xD;
             5 years.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>28 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Véronique MONDAIN, MD</last_name>
    <phone>+33 (0)4 92 03 77 77</phone>
    <email>mondain.v@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Véronique MONDAIN, MD</last_name>
      <phone>+33 (0)4 92 03 77 77</phone>
      <email>mondain.v@chu-nice.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03819712
org study id: 18-PP-05
nct id: NCT03819712
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Urinary tract infections affect more than 130 million people worldwide each year. Almost 50%
      of women will have at least one urinary tract infection during their lifetime, usually
      cystitis. Half of them will have recurrent cystitis. Antibiotics are the first-line treatment
      for cystitis, but their effectiveness is decreasing due to the rapid spread of
      multi-resistant uro-pathogenic bacteria. The objective of this study is to identify blood
      biomarkers associated with a high risk of recurrent cystitis. Immune system cells, and more
      specifically innate immunity cells, play a key role in controlling urinary tract infections.
      In addition, clinical studies have shown that there is a high inter-individual variability in
      the ability of innate immune cells to respond to different stimuli. We therefore hypothesized
      that there was an association between the risk of recurrent cystitis and a deficiency of
      certain immune cell types in producing certain pro-inflammatory cytokines, including TNF-α,
      in response to one or more bacterial stimuli, particularly flagellin.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: TNF-α measurement in blood cell culture media using Luminex® technology.
time frame: At 18 months
description: The concentrations of TNF-α will be expressed in ng/ml by calibration with a standard range.
arm group label: No recurrent UTI
arm group type: Experimental
description: Healthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years
arm group label: Recurrent UTI
arm group type: Experimental
intervention type: Procedure
intervention name: Collection of blood samples
description: 23 mL of blood will be collected during the inclusion visit
arm group label: No recurrent UTI
arm group label: Recurrent UTI
intervention type: Other
intervention name: Collection of fecal samples
description: Fecal sample self-collected after the inclusion visit
arm group label: No recurrent UTI
arm group label: Recurrent UTI
intervention type: Other
intervention name: Collection of urine samples
description: 10 mL of urine will be collected during the inclusion visit
arm group label: No recurrent UTI
arm group label: Recurrent UTI
intervention type: Other
intervention name: Collection of vaginal swaps
description: Sample of vaginal microbiota collected during the inclusion visit
arm group label: No recurrent UTI
arm group label: Recurrent UTI
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 28 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Véronique MONDAIN, MD
phone: +33 (0)4 92 03 77 77
email: mondain.v@chu-nice.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
sharing ipd: Undecided