<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/NCT02979002</url>
  </required_header>
  <id_info>
    <org_study_id>ENSP276/DGDB26012016</org_study_id>
    <nct_id>NCT02979002</nct_id>
  </id_info>
  <brief_title>Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco</brief_title>
  <official_title>Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National School of Public Health, Morocco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National School of Public Health, Morocco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to estimate the accuracy of CL Detect Rapid Test™ compared to a&#xD;
      composite reference standard test (Direct examination of skin smears + PCR test) in patients&#xD;
      with clinically suspected Cutaneous Leishmaniasis disease in Morocco.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants are recruited in nine health centers located in fourthree CL endemic&#xD;
      provinces. The RDT under evaluation (index test) is the CL Detect™ Rapid Test (InBios, USA);&#xD;
      a membrane-based amastigote antigen (peroxidoxin) detection test. The reference standard&#xD;
      consists of two tests: direct examination of skin smears and PCR. For each patient, the&#xD;
      health professional takes one dental broach sample and four skin smear samples from a single&#xD;
      lesion. The dental broach sample is used for the RDT, which is done once. The skin smear&#xD;
      samples are sent to provincial laboratories for microscopy testing and to reference&#xD;
      laboratories in Morocco and Belgium for PCR testing by ITS1 PCR, Hsp70 genotyping and&#xD;
      parasite load determination. Readers of index and reference tests do not have access to&#xD;
      clinical information or any other test results. The results of the test under evaluation&#xD;
      (RDT) and the molecular tests (PCR) are not communicated to the patient or her/his physician,&#xD;
      as case management has to follow current clinical guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Positive result for this test</measure>
    <time_frame>50 minutes</time_frame>
  </primary_outcome>
  <enrollment type="Actual">219</enrollment>
  <condition>Cutaneous Leishmaniasis</condition>
  <condition>Skin Diseases, Parasitic</condition>
  <condition>Neglected Diseases</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Suspected Cutaneous leishmaniasis lesions&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Primary health centers in Morocco&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with suspected Cutaneous Leishmaniasis wound(s) in apparently healthy&#xD;
             state&#xD;
&#xD;
          -  Who is able to learn the Information sheet and sign the Informed consent form by them&#xD;
             selves or by their parents with the presence or not of a witness (for illiterate&#xD;
             people)&#xD;
&#xD;
          -  Who satisfy the following criteria :&#xD;
&#xD;
               -  with an ulcerative lesion in any accessible part of the body to perform the&#xD;
                  dental broach and the scraping.&#xD;
&#xD;
               -  Just one ulcerative lesion by patient could be selected (The newest and the less&#xD;
                  infected)&#xD;
&#xD;
               -  Lesion should be less than 04 months of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with only nodular, papular, macular or nodulo-papular suspected CL forms&#xD;
&#xD;
          -  Patients with ulcerative lesions with a suspected bacteria origin which could&#xD;
             disappear after a short course of antibiotic treatment.&#xD;
&#xD;
          -  Patients who already received during the last two months, prior to signing the&#xD;
             consent, a physical treatment (e.g. cryotherapy, thermotherapy, Laser) or a&#xD;
             traditional treatment (e.g. burn, acide, traditional scraping)&#xD;
&#xD;
          -  Patients presenting other disease with the need to take anti-parasite treatments&#xD;
&#xD;
          -  Patient with a acute or chronic disease needing hospitalization&#xD;
&#xD;
          -  Patient who already received antimoniate treatment incomplete or complete duration and&#xD;
             dose against CL&#xD;
&#xD;
          -  Any situation that could engage the security of the patient or of the health&#xD;
             professional (e.g. People with a psychiatric trouble or a mental handicap )&#xD;
&#xD;
          -  For children less than 12 years old, the decision of participation is mainly based on&#xD;
             the condition that their parents are able to learn and understand the information&#xD;
             sheet and sign the informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Issam Bennis, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>National School of Public Health - Rabat - Morocco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary Health center</name>
      <address>
        <city>Erfoud</city>
        <state>Errachidia</state>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health primary center</name>
      <address>
        <city>Tinejdad</city>
        <state>Errachidia</state>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Center</name>
      <address>
        <city>Sekoura</city>
        <state>Ouarzazates</state>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Center</name>
      <address>
        <city>Tarmight</city>
        <state>Ouarzazates</state>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Center</name>
      <address>
        <city>Tazouta</city>
        <state>Sefrou</state>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Center</name>
      <address>
        <city>Boumalne</city>
        <state>Tinghir</state>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Center</name>
      <address>
        <city>Kelaat Mgouna</city>
        <state>Tinghir</state>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Center</name>
      <address>
        <city>Sefrou</city>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Center</name>
      <address>
        <city>Sidi Kacem</city>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Morocco</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>August 6, 2017</last_update_submitted>
  <last_update_submitted_qc>August 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National School of Public Health, Morocco</investigator_affiliation>
    <investigator_full_name>Issam Bennis, MD</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leishmaniasis</mesh_term>
    <mesh_term>Leishmaniasis, Cutaneous</mesh_term>
    <mesh_term>Parasitic Diseases</mesh_term>
    <mesh_term>Skin Diseases, Parasitic</mesh_term>
    <mesh_term>Skin Diseases</mesh_term>
    <mesh_term>Neglected Diseases</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/NCT02979002
org study id: ENSP276/DGDB26012016
nct id: NCT02979002
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to estimate the accuracy of CL Detect Rapid Test™ compared to a
      composite reference standard test (Direct examination of skin smears + PCR test) in patients
      with clinically suspected Cutaneous Leishmaniasis disease in Morocco.
Study participants are recruited in nine health centers located in fourthree CL endemic
      provinces. The RDT under evaluation (index test) is the CL Detect™ Rapid Test (InBios, USA);
      a membrane-based amastigote antigen (peroxidoxin) detection test. The reference standard
      consists of two tests: direct examination of skin smears and PCR. For each patient, the
      health professional takes one dental broach sample and four skin smear samples from a single
      lesion. The dental broach sample is used for the RDT, which is done once. The skin smear
      samples are sent to provincial laboratories for microscopy testing and to reference
      laboratories in Morocco and Belgium for PCR testing by ITS1 PCR, Hsp70 genotyping and
      parasite load determination. Readers of index and reference tests do not have access to
      clinical information or any other test results. The results of the test under evaluation
      (RDT) and the molecular tests (PCR) are not communicated to the patient or her/his physician,
      as case management has to follow current clinical guidelines.
observational model: Cohort
time perspective: Prospective
measure: Positive result for this test
time frame: 50 minutes
Suspected Cutaneous leishmaniasis lesions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Issam Bennis, MD, MPH
role: Principal Investigator
affiliation: National School of Public Health - Rabat - Morocco
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Morocco
responsible party type: Principal Investigator
investigator affiliation: National School of Public Health, Morocco
investigator full name: Issam Bennis, MD
investigator title: Doctor
mesh term: Leishmaniasis
mesh term: Leishmaniasis, Cutaneous
mesh term: Parasitic Diseases
mesh term: Skin Diseases, Parasitic
mesh term: Skin Diseases
mesh term: Neglected Diseases
sharing ipd: Undecided