<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/NCT01663831</url>
  </required_header>
  <id_info>
    <org_study_id>OPP1032354</org_study_id>
    <nct_id>NCT01663831</nct_id>
  </id_info>
  <brief_title>Repellents as Added Control Measure to Long Lasting Insecticidal Nets</brief_title>
  <acronym>MalaResT</acronym>
  <official_title>Repellents as Added Control Measure to Long Lasting Insecticidal Nets to Target the Residual Transmission in Southeast Asia: a Step Forwards to Malaria Elimination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NCHADS - Ministry of Health of Cambodia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut Pasteur</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Tropical Medicine, Belgium</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The scaling up of Long Lasting Insecticidal Nets (LLIN) and the expansion of Indoor Residual&#xD;
      Spraying (IRS) has contributed to a significant decrease of malaria worldwide. However these&#xD;
      control methods tackle only indoor and night biting vectors. The proportion of transmission&#xD;
      occurring outdoors and before sleeping hours or so-called &quot;residual transmission&quot; is steadily&#xD;
      increasing and may compromise the effort towards malaria elimination.&#xD;
&#xD;
      The purpose of this study is to raise evidence on the effectiveness of mass use of topical&#xD;
      repellents in addition to LLINs in controlling malaria infections.&#xD;
&#xD;
      A multidisciplinary approach will be used to collect information on the most important&#xD;
      factors that contribute to the successful reduction of &quot;residual malaria transmission&quot;. In a&#xD;
      first objective the epidemiological efficacy of repellents on prevalence of malaria carriers&#xD;
      and malaria incidence will be assessed. To achieve this goal 98 communities will be randomly&#xD;
      assigned to one of two treatment arms (LLIN and LLIN + repellent). Within a community a cross&#xD;
      sectional random sample of 65 people will be drawn at the beginning and the end of the&#xD;
      malaria season to obtain an estimate of the malaria prevalence. The second objective will&#xD;
      handle the entomological efficacy and persistence of the topical repellent on malaria&#xD;
      vectors. And lastly the acceptability, adherence and adequacy of the topical repellents will&#xD;
      be studied in a third objective.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in malaria prevalence at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Malaria prevalence (PCR detection) will be measured in both study arms at the start and end of the malaria season for 2 consecutive years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malaria incidence</measure>
    <time_frame>6 months</time_frame>
    <description>Through passive RDT case detection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40000</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>Topical Repellent &amp; LLIN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Long Lasting Insecticidal Nets</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Brand Name LLIN: Olyset Net&#xD;
Active ingredient: permethrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mosquito topical repellent</intervention_name>
    <description>Daily repellent use, before and after sleeping hours during the malaria season (6 months) in addition to the use of Long Lasting Insecticidal Nets during sleeping hours.</description>
    <arm_group_label>Topical Repellent &amp; LLIN</arm_group_label>
    <other_name>Brand name: Autan</other_name>
    <other_name>Active ingredient: Icaridin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All household members volunteering from selected communities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants less than 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Coosemans, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Tropical Medicine Antwerp</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Banlung</city>
        <state>Ratanakiri</state>
        <country>Cambodia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cambodia</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>July 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>January 31, 2014</last_update_submitted>
  <last_update_submitted_qc>January 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Outdoor Malaria Transmission</keyword>
  <keyword>Anopheles</keyword>
  <keyword>Topical repellent</keyword>
  <keyword>Early biting vector</keyword>
  <keyword>Long Lasting Insecticidal Net (LLIN)</keyword>
  <keyword>Cambodia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</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/NCT01663831
org study id: OPP1032354
nct id: NCT01663831
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The scaling up of Long Lasting Insecticidal Nets (LLIN) and the expansion of Indoor Residual
      Spraying (IRS) has contributed to a significant decrease of malaria worldwide. However these
      control methods tackle only indoor and night biting vectors. The proportion of transmission
      occurring outdoors and before sleeping hours or so-called "residual transmission" is steadily
      increasing and may compromise the effort towards malaria elimination.

      The purpose of this study is to raise evidence on the effectiveness of mass use of topical
      repellents in addition to LLINs in controlling malaria infections.

      A multidisciplinary approach will be used to collect information on the most important
      factors that contribute to the successful reduction of "residual malaria transmission". In a
      first objective the epidemiological efficacy of repellents on prevalence of malaria carriers
      and malaria incidence will be assessed. To achieve this goal 98 communities will be randomly
      assigned to one of two treatment arms (LLIN and LLIN + repellent). Within a community a cross
      sectional random sample of 65 people will be drawn at the beginning and the end of the
      malaria season to obtain an estimate of the malaria prevalence. The second objective will
      handle the entomological efficacy and persistence of the topical repellent on malaria
      vectors. And lastly the acceptability, adherence and adequacy of the topical repellents will
      be studied in a third objective.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from baseline in malaria prevalence at 6 months
time frame: 6 months
description: Malaria prevalence (PCR detection) will be measured in both study arms at the start and end of the malaria season for 2 consecutive years.
measure: Malaria incidence
time frame: 6 months
description: Through passive RDT case detection
arm group label: Topical Repellent & LLIN
arm group type: Experimental
arm group label: Long Lasting Insecticidal Nets
arm group type: No Intervention
description: Brand Name LLIN: Olyset Net
Active ingredient: permethrin
intervention type: Other
intervention name: Mosquito topical repellent
description: Daily repellent use, before and after sleeping hours during the malaria season (6 months) in addition to the use of Long Lasting Insecticidal Nets during sleeping hours.
arm group label: Topical Repellent & LLIN
other name: Brand name: Autan
other name: Active ingredient: Icaridin
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marc Coosemans, Professor
role: Principal Investigator
affiliation: Institute of Tropical Medicine Antwerp
facility: 
country: Cambodia
responsible party type: Sponsor
mesh term: Malaria