<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/NCT04505046</url>
  </required_header>
  <id_info>
    <org_study_id>CEI-005/2020</org_study_id>
    <nct_id>NCT04505046</nct_id>
  </id_info>
  <brief_title>Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections.</brief_title>
  <acronym>INSPiRED-WP3</acronym>
  <official_title>Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Plasmodium Falciparum, Schistosoma Haematobium and Necator Americanus at CERMEL, Gabon.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre de Recherche Médicale de Lambaréné</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre de Recherche Médicale de Lambaréné</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>
      Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect&#xD;
      hundreds of millions of people and are an important cause of global mortality and morbidity.&#xD;
      For the control of these poverty related parasitic diseases, and to complement&#xD;
      chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial&#xD;
      role.&#xD;
&#xD;
      In recent years, innovative smart mobile technologies have been applied for detection and&#xD;
      identification of cultured parasite species, which is basically based on sample imaging and&#xD;
      parasite morphology identification. Promising advances have been made with this technology&#xD;
      and coupled with its small size, low cost and easy to manipulate, makes it suitable for point&#xD;
      of care diagnostics in low resource setting.&#xD;
&#xD;
      The aim of the proposed explorative study is to further validate sensitivity and specificity&#xD;
      of each of the developed devices, using besides microscopy a range of more advanced reference&#xD;
      tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect&#xD;
      hundreds of millions of people and are an important cause of global mortality and morbidity.&#xD;
      For the control of these poverty related parasitic diseases, and to complement&#xD;
      chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial&#xD;
      role. Especially in remote and/or low resource settings, appropriate diagnostic tests are&#xD;
      often lacking. These tests should not only be sensitive and specific, but also affordable,&#xD;
      reliable, and easy to operate. In recent years, innovative smart mobile technologies have&#xD;
      been applied for detection and identification of cultured parasite species, which is&#xD;
      basically based on sample imaging and parasite morphology identification. Promising advances&#xD;
      have been made with this technology and coupled with its small size, low cost and easy to&#xD;
      manipulate, makes it suitable for point of care diagnostics in low resource setting. At the&#xD;
      Technical University of Delft, a smart optical device prototype has been recently developed&#xD;
      for the detection of Plasmodium. This Excelscope has been tested on a small number of malaria&#xD;
      cases in Nigeria, showing promising results. In addition, TU Delft has developed a prototype&#xD;
      for the detection of Schistosoma haematobium eggs in urine, which is ready for further&#xD;
      validation in the field. Still under construction is a smart optical device for the detection&#xD;
      of helminth eggs in stool, including eggs of hookworms. For each of these three smart optical&#xD;
      devices using respectively blood, urine or stool, a diagnostic performance is aimed which&#xD;
      does not significantly deviate in sensitivity and specificity from the diagnostic tests&#xD;
      commonly in use in low resource settings, e.g. basic microscopy. At the same time, the&#xD;
      optical devices have supplementary logistical advantages, e.g. easiness to use, high&#xD;
      throughput and low costs per sample. The aim of the proposed explorative study is to further&#xD;
      validate sensitivity and specificity of each of the developed devices, using besides&#xD;
      microscopy a range of more advanced reference tests. For this purpose, diagnostic samples&#xD;
      (blood, urine, stool) collected from ongoing studies involving malaria, schistosomiasis and&#xD;
      STHs. at CERMEL will be used. The outcome of this study will give new insight in the&#xD;
      diagnostic performance of the innovative smart optical devices, specifically in comparison to&#xD;
      the WHO recommended diagnostic procedures currently used at CERMEL. The study is the core&#xD;
      activity of Work Package 3 within the INSPiRED project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>AiDx devise is good as a conventional microscopy</measure>
    <time_frame>3 years</time_frame>
    <description>Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schistoscope</measure>
    <time_frame>3 years</time_frame>
    <description>Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hookworm and other STH devise is good as conventional. microscopic test</measure>
    <time_frame>3 years</time_frame>
    <description>Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test</description>
  </primary_outcome>
  <enrollment type="Anticipated">460</enrollment>
  <condition>Testing</condition>
  <condition>Performance</condition>
  <condition>Specificity</condition>
  <condition>Sensitivity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All study participants, living in Lambaréné areas and its surrounding with parasitic&#xD;
        infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infected with malaria&#xD;
&#xD;
          -  Infected with Schistosomiasis&#xD;
&#xD;
          -  Soil-transmitted helminths&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -No sample provided&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romuald Mba, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Centre de Recherches Médicales de Lambaréné - CERMEL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ayola A ADEGNIKA, PhD; MD</last_name>
    <phone>+2466244472</phone>
    <email>aadegnika@cermel.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brice Meulah, MsC</last_name>
    <phone>+24174567447</phone>
    <email>meulahfabrice@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de Recherches Medicales de Lambarene</name>
      <address>
        <city>Lambaréné</city>
        <state>Moyen Ogooué</state>
        <zip>BP 242</zip>
        <country>Gabon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ayola A ADEGNIKA</last_name>
      <phone>06244472</phone>
      <email>aadegnika@cermel.org</email>
    </contact>
    <contact_backup>
      <last_name>Brice Meulah</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Gabon</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plasmodium</keyword>
  <keyword>Schistosoma</keyword>
  <keyword>hookworm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT04505046
org study id: CEI-005/2020
nct id: NCT04505046
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect
      hundreds of millions of people and are an important cause of global mortality and morbidity.
      For the control of these poverty related parasitic diseases, and to complement
      chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial
      role.

      In recent years, innovative smart mobile technologies have been applied for detection and
      identification of cultured parasite species, which is basically based on sample imaging and
      parasite morphology identification. Promising advances have been made with this technology
      and coupled with its small size, low cost and easy to manipulate, makes it suitable for point
      of care diagnostics in low resource setting.

      The aim of the proposed explorative study is to further validate sensitivity and specificity
      of each of the developed devices, using besides microscopy a range of more advanced reference
      tests.
Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect
      hundreds of millions of people and are an important cause of global mortality and morbidity.
      For the control of these poverty related parasitic diseases, and to complement
      chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial
      role. Especially in remote and/or low resource settings, appropriate diagnostic tests are
      often lacking. These tests should not only be sensitive and specific, but also affordable,
      reliable, and easy to operate. In recent years, innovative smart mobile technologies have
      been applied for detection and identification of cultured parasite species, which is
      basically based on sample imaging and parasite morphology identification. Promising advances
      have been made with this technology and coupled with its small size, low cost and easy to
      manipulate, makes it suitable for point of care diagnostics in low resource setting. At the
      Technical University of Delft, a smart optical device prototype has been recently developed
      for the detection of Plasmodium. This Excelscope has been tested on a small number of malaria
      cases in Nigeria, showing promising results. In addition, TU Delft has developed a prototype
      for the detection of Schistosoma haematobium eggs in urine, which is ready for further
      validation in the field. Still under construction is a smart optical device for the detection
      of helminth eggs in stool, including eggs of hookworms. For each of these three smart optical
      devices using respectively blood, urine or stool, a diagnostic performance is aimed which
      does not significantly deviate in sensitivity and specificity from the diagnostic tests
      commonly in use in low resource settings, e.g. basic microscopy. At the same time, the
      optical devices have supplementary logistical advantages, e.g. easiness to use, high
      throughput and low costs per sample. The aim of the proposed explorative study is to further
      validate sensitivity and specificity of each of the developed devices, using besides
      microscopy a range of more advanced reference tests. For this purpose, diagnostic samples
      (blood, urine, stool) collected from ongoing studies involving malaria, schistosomiasis and
      STHs. at CERMEL will be used. The outcome of this study will give new insight in the
      diagnostic performance of the innovative smart optical devices, specifically in comparison to
      the WHO recommended diagnostic procedures currently used at CERMEL. The study is the core
      activity of Work Package 3 within the INSPiRED project.
observational model: Cohort
time perspective: Prospective
measure: AiDx devise is good as a conventional microscopy
time frame: 3 years
description: Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
measure: Schistoscope
time frame: 3 years
description: Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
measure: Hookworm and other STH devise is good as conventional. microscopic test
time frame: 3 years
description: Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Romuald Mba, MSc
role: Study Chair
affiliation: Centre de Recherches Médicales de Lambaréné - CERMEL
last name: Ayola A ADEGNIKA, PhD; MD
phone: +2466244472
email: aadegnika@cermel.org
last name: Brice Meulah, MsC
phone: +24174567447
email: meulahfabrice@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Gabon
responsible party type: Sponsor
mesh term: Respiratory Aspiration
mesh term: Hypersensitivity