<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/NCT03289663</url>
  </required_header>
  <id_info>
    <org_study_id>NET-06-08-76</org_study_id>
    <nct_id>NCT03289663</nct_id>
  </id_info>
  <brief_title>Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo</brief_title>
  <acronym>Net-PBO</acronym>
  <official_title>Effectiveness Study of Bednets Treated With Synegistic Combination of Insectcides in an Area With Pyrethroid-resistant Vectors in the Democratic Republic of the Congo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Lubumbashi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Lubumbashi</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control&#xD;
      strategy, populations are still continuously exposed to a high frequency of malarial&#xD;
      inoculation in some countries. The situation can be explained by a swift increase in the&#xD;
      resistance of Anopheles to common insecticides. To preserve the gains of insecticides and&#xD;
      improve their effectiveness, a new generation of bednets treated with piperonyl butoxide&#xD;
      combination insectides have emerged.But more evidence is needed to plead for scale up of&#xD;
      their usage. The lack of information relating to the additional impact of that combination on&#xD;
      the transmission of Malaria, its relative efficacy in real-life setting and its safety in&#xD;
      users are the rationale for more investigation.This will be a randomized controlled study on&#xD;
      a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be&#xD;
      recruited to compute the effectiveness of this new tool.&#xD;
&#xD;
      The findings will be useful information for decision-making by national malaria control&#xD;
      programs, their partners, the international community and the bednet manufacturers with&#xD;
      regard to the effectiveness of the new combination of insecticides in real-life context. The&#xD;
      results will also enable a better design of the tool in the future and a broader&#xD;
      understanding of long-term dynamics for sustainability, as well as identification of some&#xD;
      factors with negative impacts on the benefits of the strategy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Cluster-randomized trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The 2 groups of villages will randomly receive either the bednets treated with conventional insecticide (Pyrethroid) or the synergistic combination of insecticides. None of the groups knows which bednets they receive.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of laboratory confirmed clinical cases of Malaria</measure>
    <time_frame>Participants will be actively followed up for 12 months. And any suspected case of clinical Malaria will immediately lead to microscopy and RDT for confirmation</time_frame>
    <description>Microscopy to confirm the diagnosis of Malaria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sporozoite rate</measure>
    <time_frame>Anopheles mosquitoes will be captured every 3 months during 1 year</time_frame>
    <description>Sporozoite detection by ELISA to determine infectivity of anopheles</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1680</enrollment>
  <condition>Insecticide Resistance</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The arm will receive bednets treated with conventional insecticide (Pyrethroid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The arm will receive bednets treated with new generation of insecticides (synergistic combination of insecticides)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>synergistic combination of insecticides</intervention_name>
    <description>third generation insecticide -treated bednets</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pyrethroids</intervention_name>
    <description>Conventional insecticide</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria : -households where there are one or more children below the age of 10&#xD;
        years;&#xD;
&#xD;
          -  Ability and willingness of the head of the household to participate based on signed&#xD;
             informed consent (or fingerprint) and with the assistance of an impartial witness (if&#xD;
             the head of the household is illiterate)&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  refusal of the head of household to participate&#xD;
&#xD;
          -  known allergy to insecticides&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Général de Référence Saint Luc</name>
      <address>
        <city>Kisantu</city>
        <state>Kongo-Central</state>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Congo, The Democratic Republic of the</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Public Health, Democratic Republic of the Congo</investigator_affiliation>
    <investigator_full_name>Gillon Ilombe Kaounga</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>synergistic combination</keyword>
  <keyword>insecticide resistance</keyword>
  <keyword>vectors</keyword>
  <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/NCT03289663
org study id: NET-06-08-76
nct id: NCT03289663
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control
      strategy, populations are still continuously exposed to a high frequency of malarial
      inoculation in some countries. The situation can be explained by a swift increase in the
      resistance of Anopheles to common insecticides. To preserve the gains of insecticides and
      improve their effectiveness, a new generation of bednets treated with piperonyl butoxide
      combination insectides have emerged.But more evidence is needed to plead for scale up of
      their usage. The lack of information relating to the additional impact of that combination on
      the transmission of Malaria, its relative efficacy in real-life setting and its safety in
      users are the rationale for more investigation.This will be a randomized controlled study on
      a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be
      recruited to compute the effectiveness of this new tool.

      The findings will be useful information for decision-making by national malaria control
      programs, their partners, the international community and the bednet manufacturers with
      regard to the effectiveness of the new combination of insecticides in real-life context. The
      results will also enable a better design of the tool in the future and a broader
      understanding of long-term dynamics for sustainability, as well as identification of some
      factors with negative impacts on the benefits of the strategy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster-randomized trial
primary purpose: Prevention
masking: Single (Participant)
masking description: The 2 groups of villages will randomly receive either the bednets treated with conventional insecticide (Pyrethroid) or the synergistic combination of insecticides. None of the groups knows which bednets they receive.
measure: Incidence rate of laboratory confirmed clinical cases of Malaria
time frame: Participants will be actively followed up for 12 months. And any suspected case of clinical Malaria will immediately lead to microscopy and RDT for confirmation
description: Microscopy to confirm the diagnosis of Malaria
measure: Sporozoite rate
time frame: Anopheles mosquitoes will be captured every 3 months during 1 year
description: Sporozoite detection by ELISA to determine infectivity of anopheles
arm group label: Control
arm group type: Active Comparator
description: The arm will receive bednets treated with conventional insecticide (Pyrethroid)
arm group label: Experimental
arm group type: Experimental
description: The arm will receive bednets treated with new generation of insecticides (synergistic combination of insecticides)
intervention type: Drug
intervention name: synergistic combination of insecticides
description: third generation insecticide -treated bednets
arm group label: Experimental
intervention type: Drug
intervention name: Pyrethroids
description: Conventional insecticide
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Congo, The Democratic Republic of the
responsible party type: Principal Investigator
investigator affiliation: Ministry of Public Health, Democratic Republic of the Congo
investigator full name: Gillon Ilombe Kaounga
investigator title: Researcher
sharing ipd: Undecided