<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/NCT03784248</url>
  </required_header>
  <id_info>
    <org_study_id>17-API-02</org_study_id>
    <nct_id>NCT03784248</nct_id>
  </id_info>
  <brief_title>Mediterranean Visceral Leishmaniasis With Leishmania Infantum</brief_title>
  <acronym>AsymptoGen</acronym>
  <official_title>Mediterranean Visceral Leishmaniasis With Leishmania Infantum: Genetic Characterization of the Host Parasite in Relation to Asymptomatic Human Carriage</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>
      L. infantum leishmaniasis is endemic in the South of France. For several years, there has&#xD;
      been an expansion of the territory of sandflies (vector of leishmaniasis), with the&#xD;
      appearance of cases of canine leishmaniasis in new outbreaks: West of the Occitania region&#xD;
      (South-West). The transition from asymptomatic to disease depends largely on the immune&#xD;
      status of the carrier, but many other factors specific to the parasite and host remain poorly&#xD;
      defined. Asymptomatic carriage is present in a large majority of infected subjects, however,&#xD;
      to date, only parasite isolates causing the patent form have been characterized.&#xD;
&#xD;
      In this PHRC, the team wishes to study the genetics of parasite isolates present in&#xD;
      asymptomatic carriers of the Alpes-Maritimes outbreak and the new Occitanie outbreak as well&#xD;
      as the genetics of the host.&#xD;
&#xD;
      The primary objective is the genetic characterization of L. infantum isolates by the&#xD;
      microsatellite method, present in asymptomatic carriers in southeast and southwestern France.&#xD;
&#xD;
      The secondary objectives are:&#xD;
&#xD;
        1. Comparison of the genetic profiles of L. infantum isolates, by microsatellite method,&#xD;
           from asymptomatic carriers of the new Southwestern outbreak with isolates from&#xD;
           asymptomatic carriers of the historical Southwestern outbreak.&#xD;
&#xD;
        2. Comparison of the genetic profiles of L. infantum isolates, by the microsatellite&#xD;
           method, present in asymptomatic carriers in the Southeast with the profiles of isolates&#xD;
           present in patients in the same outbreak, for whom a microsatellite study has already&#xD;
           been obtained previously.&#xD;
&#xD;
        3. the team is also conducting a preliminary study of the host genetic factors that would&#xD;
           be associated with asymptomatic carriage by studying the association between potential&#xD;
           host-related genetic risk factors (HLA typing, NLRP3 gene study) and asymptomatic&#xD;
           carriage. Indeed, a recent study showed that the NLRP3 gene prevents the development of&#xD;
           the patent form of leishmaniasis in the mouse model. This preliminary genetic study will&#xD;
           identify potential host-related factors associated with asymptomatic carriage.&#xD;
&#xD;
      To meet these objectives, leuco-platelet layer parasites (CLP) obtained via EFS from the 2&#xD;
      sources of interest will be isolated.&#xD;
&#xD;
      This project is a research not involving the human person. It is multicentric and&#xD;
      non-randomized.&#xD;
&#xD;
      As a result of this research, isolates from asymptomatic carriers of the historical outbreak&#xD;
      will be studied and compared to those present in new endemic outbreaks, as well as to those&#xD;
      of patients already studied in a previous study. A better knowledge of parasites circulating&#xD;
      in asymptomatic carriers will make it possible to study in a comprehensive way the risk&#xD;
      factors associated with the parasite. In addition, the study of asymptomatic carrying in new&#xD;
      endemic outbreaks such as Occitania is very original, since no human studies have yet been&#xD;
      undertaken in this region. The results obtained in this PHRC will be used to understand the&#xD;
      factors associated with the development of visceral leishmaniasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 3, 2019</start_date>
  <completion_date type="Anticipated">August 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>genetic level characterization of the isolates of L. infantum</measure>
    <time_frame>6 months</time_frame>
    <description>To characterize at the genetic level the isolates of L. infantum present in asymptomatic carriers in South-East and South-West France, it will be studied12 microsatellite loci by PCR - laboratory tests</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Leishmaniasis</condition>
  <arm_group>
    <arm_group_label>asymptomatic carrier</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>uninfected subjects</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood donation and isolation of leuco-platelet layers</intervention_name>
    <description>patients donating blood. Blood bags will be treated and leuco-platelet coatings will be sent to Nice</description>
    <arm_group_label>asymptomatic carrier</arm_group_label>
    <arm_group_label>uninfected subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anyone aged 18 to 70, who weighs more than 50 kg and is recognized as fit following the&#xD;
        predon interview, can donate blood.&#xD;
&#xD;
        Men can give up to 6 times a year and women up to 4 times. Between two blood donations, a&#xD;
        minimum of 8 weeks must be respected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet EFS blood donation criteria&#xD;
&#xD;
          -  Provenance:&#xD;
&#xD;
        Department of Alpes-Maritimes, Var and Bouches du Rhône, for the historical endemic&#xD;
        outbreak Department of Gers, Tarn-et-Garonne and Lot for the new Occitanie household&#xD;
&#xD;
        - Donor who has signed genetic consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  criteria for EFS blood donation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nice Hospital</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christelle POMARES, MCUPH</last_name>
      <phone>33492036254</phone>
      <email>pomares.c@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Christelle POMARES, MCUPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gregory MICHEL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</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>Leishmaniasis</mesh_term>
    <mesh_term>Leishmaniasis, Visceral</mesh_term>
  </condition_browse>
  <!-- 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/NCT03784248
org study id: 17-API-02
nct id: NCT03784248
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
L. infantum leishmaniasis is endemic in the South of France. For several years, there has
      been an expansion of the territory of sandflies (vector of leishmaniasis), with the
      appearance of cases of canine leishmaniasis in new outbreaks: West of the Occitania region
      (South-West). The transition from asymptomatic to disease depends largely on the immune
      status of the carrier, but many other factors specific to the parasite and host remain poorly
      defined. Asymptomatic carriage is present in a large majority of infected subjects, however,
      to date, only parasite isolates causing the patent form have been characterized.

      In this PHRC, the team wishes to study the genetics of parasite isolates present in
      asymptomatic carriers of the Alpes-Maritimes outbreak and the new Occitanie outbreak as well
      as the genetics of the host.

      The primary objective is the genetic characterization of L. infantum isolates by the
      microsatellite method, present in asymptomatic carriers in southeast and southwestern France.

      The secondary objectives are:

        1. Comparison of the genetic profiles of L. infantum isolates, by microsatellite method,
           from asymptomatic carriers of the new Southwestern outbreak with isolates from
           asymptomatic carriers of the historical Southwestern outbreak.

        2. Comparison of the genetic profiles of L. infantum isolates, by the microsatellite
           method, present in asymptomatic carriers in the Southeast with the profiles of isolates
           present in patients in the same outbreak, for whom a microsatellite study has already
           been obtained previously.

        3. the team is also conducting a preliminary study of the host genetic factors that would
           be associated with asymptomatic carriage by studying the association between potential
           host-related genetic risk factors (HLA typing, NLRP3 gene study) and asymptomatic
           carriage. Indeed, a recent study showed that the NLRP3 gene prevents the development of
           the patent form of leishmaniasis in the mouse model. This preliminary genetic study will
           identify potential host-related factors associated with asymptomatic carriage.

      To meet these objectives, leuco-platelet layer parasites (CLP) obtained via EFS from the 2
      sources of interest will be isolated.

      This project is a research not involving the human person. It is multicentric and
      non-randomized.

      As a result of this research, isolates from asymptomatic carriers of the historical outbreak
      will be studied and compared to those present in new endemic outbreaks, as well as to those
      of patients already studied in a previous study. A better knowledge of parasites circulating
      in asymptomatic carriers will make it possible to study in a comprehensive way the risk
      factors associated with the parasite. In addition, the study of asymptomatic carrying in new
      endemic outbreaks such as Occitania is very original, since no human studies have yet been
      undertaken in this region. The results obtained in this PHRC will be used to understand the
      factors associated with the development of visceral leishmaniasis.
observational model: Ecologic or Community
time perspective: Prospective
measure: genetic level characterization of the isolates of L. infantum
time frame: 6 months
description: To characterize at the genetic level the isolates of L. infantum present in asymptomatic carriers in South-East and South-West France, it will be studied12 microsatellite loci by PCR - laboratory tests
arm group label: asymptomatic carrier
arm group label: uninfected subjects
intervention type: Other
intervention name: blood donation and isolation of leuco-platelet layers
description: patients donating blood. Blood bags will be treated and leuco-platelet coatings will be sent to Nice
arm group label: asymptomatic carrier
arm group label: uninfected subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Leishmaniasis
mesh term: Leishmaniasis, Visceral