<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/NCT01713517</url>
  </required_header>
  <id_info>
    <org_study_id>WHO_IR_SUDAN</org_study_id>
    <nct_id>NCT01713517</nct_id>
  </id_info>
  <brief_title>Impact of Insecticide Resistance on Vector Control</brief_title>
  <official_title>Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal Ministry of Health, Sudan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liverpool School of Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine whether long lasting insecticidal nets and indoor&#xD;
      residual insecticide spraying, alone or in combination, are effective for controlling&#xD;
      insecticide resistant anopheles mosquitoes for malaria prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will assess the impact that insecticide resistance has on the effectiveness of&#xD;
      malaria vector control tools LLIN and IRS. This is done by a cluster randomised trials of&#xD;
      universal coverage LLINs versus universal coverage LLINs in combination with IRS, with levels&#xD;
      of baseline insecticide resistance in the main vector balanced between the two study arms. In&#xD;
      each cluster resistance to the insecticide used on LLINs is monitored, and malaria incidence&#xD;
      is estimated from cluster specific cohorts of children followed up over the duration of the&#xD;
      study. Resistance impact will be assessed from the ratio of incidence rates in clusters with&#xD;
      high compared to those with low resistance and from a continuous measure of resistance&#xD;
      expressed as percentage loss of mosquito mortality when exposed to insecticide in&#xD;
      standardised WHO tests. Resistance mechanisms will be studied in subsets of study clusters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Malaria Incidence</measure>
    <time_frame>3 years</time_frame>
    <description>Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (&gt;37.5C)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of P.falciparum Infection</measure>
    <time_frame>3 years</time_frame>
    <description>Infection with plasmodial parasites (falciparum and/or vivax) in randomly selected members of the study cohort in each study cluster during the peak of the malaria transmission season by rapid diagnostic test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Entomological Innoculation rate</measure>
    <time_frame>Average for months Sept, Oct, Nov for years 2011, 2012, 2013</time_frame>
    <description>Anopheles arabiensis mosquitoes collected in sentinel clusters by light trap, window trap, clay pot and pyrethrum sheet collection and determination of sporozoite, human blood index, feeding and resting behaviour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis</measure>
    <time_frame>Yearly average 2011, 2012, 2013, 2014</time_frame>
    <description>Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">28000</enrollment>
  <condition>Malaria, Falciparum</condition>
  <arm_group>
    <arm_group_label>Universal coverage of Long Lasting Insecticidal Nets (LLIN)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LLIN Plus Indoor Residual Spraying</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons plus indoor residual spraying with insecticide of interior walls of all houses twice yearly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Indoor residual insecticide spraying (IRS)</intervention_name>
    <description>Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal</description>
    <arm_group_label>LLIN Plus Indoor Residual Spraying</arm_group_label>
    <other_name>IRS</other_name>
    <other_name>Pesticide</other_name>
    <other_name>Bendiocarb</other_name>
    <other_name>Deltamethrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Long Lasting Insecticidal Nets (LLIN)</intervention_name>
    <description>Provision of LLIN to all community members in the clusters allocated to the study arm. LLIN protect individuals from bites by malaria vector mosquitoes by providing a physical barrier and insecticidal and repellent effect.</description>
    <arm_group_label>LLIN Plus Indoor Residual Spraying</arm_group_label>
    <arm_group_label>Universal coverage of Long Lasting Insecticidal Nets (LLIN)</arm_group_label>
    <other_name>Insecticide Treated Nets (ITN)</other_name>
    <other_name>Permanet2.0</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children older than 6 months and younger than 10 years in approximately 100 randomly&#xD;
             selected households in all 140 study clusters selected in the four study areas&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children living in households within 1 km from the edge of a neighbouring cluster (the&#xD;
             buffer zone)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Immo Kleinschmidt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin J Donnelly, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool School of Tropical Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khalid A Elmardi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Federal Ministry of Health, Sudan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hmooda T Kafy, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal Ministry of Health, Sudan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bashir A Ismail, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal Ministry of Health, Sudan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Ahmed A Mohamed, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal Ministry of Health, Sudan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hmooda T Kafy, MSc (London)</last_name>
    <phone>+249 123 399 994</phone>
    <email>hmoodak@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bashir A Ismail, MSc (USM)</last_name>
    <phone>+249 912938842</phone>
    <email>bashiradam69@yahoo.co.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Malaria Control Programme</name>
      <address>
        <city>Gedarif</city>
        <state>Gedarif State</state>
        <country>Sudan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anwar Banaga, MSc</last_name>
      <phone>+249 122645846</phone>
      <email>anwrbanaga@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Malaria Control Programme</name>
      <address>
        <city>Wad Medani</city>
        <state>Gezira State</state>
        <country>Sudan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sakhr B Elshiekh, MSc</last_name>
      <phone>+249 117587549</phone>
      <email>sakhr_14@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Malaria Control Programme</name>
      <address>
        <city>Kassala</city>
        <state>Kassala State</state>
        <country>Sudan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaaaldeen H Hussein, MSc</last_name>
      <phone>+249 117587536</phone>
      <email>shaaaldeen64@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Sudan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mosquito Control</keyword>
  <keyword>Insecticide Resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
    <mesh_term>Malaria, Falciparum</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/NCT01713517
org study id: WHO_IR_SUDAN
nct id: NCT01713517
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the study is to determine whether long lasting insecticidal nets and indoor
      residual insecticide spraying, alone or in combination, are effective for controlling
      insecticide resistant anopheles mosquitoes for malaria prevention.
The study will assess the impact that insecticide resistance has on the effectiveness of
      malaria vector control tools LLIN and IRS. This is done by a cluster randomised trials of
      universal coverage LLINs versus universal coverage LLINs in combination with IRS, with levels
      of baseline insecticide resistance in the main vector balanced between the two study arms. In
      each cluster resistance to the insecticide used on LLINs is monitored, and malaria incidence
      is estimated from cluster specific cohorts of children followed up over the duration of the
      study. Resistance impact will be assessed from the ratio of incidence rates in clusters with
      high compared to those with low resistance and from a continuous measure of resistance
      expressed as percentage loss of mosquito mortality when exposed to insecticide in
      standardised WHO tests. Resistance mechanisms will be studied in subsets of study clusters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Malaria Incidence
time frame: 3 years
description: Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (>37.5C)
measure: Prevalence of P.falciparum Infection
time frame: 3 years
description: Infection with plasmodial parasites (falciparum and/or vivax) in randomly selected members of the study cohort in each study cluster during the peak of the malaria transmission season by rapid diagnostic test
measure: Entomological Innoculation rate
time frame: Average for months Sept, Oct, Nov for years 2011, 2012, 2013
description: Anopheles arabiensis mosquitoes collected in sentinel clusters by light trap, window trap, clay pot and pyrethrum sheet collection and determination of sporozoite, human blood index, feeding and resting behaviour.
measure: Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis
time frame: Yearly average 2011, 2012, 2013, 2014
description: Molecular analysis of mosquito specimens caught in subset of clusters by pyrethrum spray collection.
arm group label: Universal coverage of Long Lasting Insecticidal Nets (LLIN)
arm group type: Active Comparator
description: Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons
arm group label: LLIN Plus Indoor Residual Spraying
arm group type: Experimental
description: Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons plus indoor residual spraying with insecticide of interior walls of all houses twice yearly.
intervention type: Other
intervention name: Indoor residual insecticide spraying (IRS)
description: Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal
arm group label: LLIN Plus Indoor Residual Spraying
other name: IRS
other name: Pesticide
other name: Bendiocarb
other name: Deltamethrin
intervention type: Device
intervention name: Long Lasting Insecticidal Nets (LLIN)
description: Provision of LLIN to all community members in the clusters allocated to the study arm. LLIN protect individuals from bites by malaria vector mosquitoes by providing a physical barrier and insecticidal and repellent effect.
arm group label: LLIN Plus Indoor Residual Spraying
arm group label: Universal coverage of Long Lasting Insecticidal Nets (LLIN)
other name: Insecticide Treated Nets (ITN)
other name: Permanet2.0
criteria: 
gender: All
minimum age: 6 Months
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Immo Kleinschmidt, PhD
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
last name: Martin J Donnelly, PhD
role: Principal Investigator
affiliation: Liverpool School of Tropical Medicine
last name: Khalid A Elmardi, MD
role: Study Director
affiliation: Federal Ministry of Health, Sudan
last name: Hmooda T Kafy, MSc
role: Principal Investigator
affiliation: Federal Ministry of Health, Sudan
last name: Bashir A Ismail, MSc
role: Principal Investigator
affiliation: Federal Ministry of Health, Sudan
last name: Mohamed Ahmed A Mohamed, MSc
role: Principal Investigator
affiliation: Federal Ministry of Health, Sudan
last name: Hmooda T Kafy, MSc (London)
phone: +249 123 399 994
email: hmoodak@yahoo.com
last name: Bashir A Ismail, MSc (USM)
phone: +249 912938842
email: bashiradam69@yahoo.co.uk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Sudan
responsible party type: Sponsor
mesh term: Malaria
mesh term: Malaria, Falciparum