<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/NCT01697852</url>
  </required_header>
  <id_info>
    <org_study_id>ITDCVP54</org_study_id>
    <nct_id>NCT01697852</nct_id>
  </id_info>
  <brief_title>The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention</brief_title>
  <official_title>Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Medical Research, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kilimanjaro Christian Medical Centre, Tanzania</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 study is a cluster randomised trial to compare the effectiveness of indoor residual&#xD;
      spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the&#xD;
      effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary&#xD;
      outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years,&#xD;
      measured in cross sectional surveys. Secondary outcomes include relative population density&#xD;
      for each mosquito vector species, malaria transmission as measured by entomological&#xD;
      inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers&#xD;
      including kdr, and user acceptability of LLINs compared with IRS.&#xD;
&#xD;
      Findings from this study are expected to inform decision making so that resource utilization&#xD;
      can be optimised.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">November 2012</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>Prevalence of malarial infection in children 6 months to 10 years</measure>
    <time_frame>9 months post randomisation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moderate to severe anaemia in children under 5 years</measure>
    <time_frame>9 months post randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years</measure>
    <time_frame>6 months post randomisation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Entomological Innoculation Rate</measure>
    <time_frame>Malaria season post randomisation(Average value during 6 months after randomisation)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Relative abundance of adult Anopheles mosquitoes by species</measure>
    <time_frame>Malaria season post randomisation (Average value during 6 months after randomisation)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>genotypic markers of insecticide resistance in malaria vector mosquitoes</measure>
    <time_frame>Malaria season post randomisation (Average value during 6 months after randomisation)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22300</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>LLIN plus IRS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LLIN only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LLIN by universal coverage campaign</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Indoor residual spraying with bendiocarb</intervention_name>
    <description>2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart</description>
    <arm_group_label>LLIN plus IRS</arm_group_label>
    <other_name>Ficam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LLIN by universal coverage campaign</intervention_name>
    <description>Long lasting Insecticide treated mosquito net</description>
    <arm_group_label>LLIN only</arm_group_label>
    <arm_group_label>LLIN plus IRS</arm_group_label>
    <other_name>Olyset nets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  resident in selected cluster (village)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not resident in selected cluster (village)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Rowland, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
  </overall_official>
  <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_contact>
    <last_name>Mark Rowland, PHD</last_name>
    <email>Mark.Rowland@lshtm.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Immo Kleinschmidt, PHD</last_name>
    <email>Immo.Kleinschmidt@lshtm.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>PAMVERC office</name>
      <address>
        <city>Muleba</city>
        <state>Kagera</state>
        <country>Tanzania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natacha Protopopoff, PHD</last_name>
      <email>nprotopopoff@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Natacha Protopopoff, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <reference>
    <citation>Kleinschmidt I, Schwabe C, Shiva M, Segura JL, Sima V, Mabunda SJ, Coleman M. Combining indoor residual spraying and insecticide-treated net interventions. Am J Trop Med Hyg. 2009 Sep;81(3):519-24.</citation>
    <PMID>19706925</PMID>
  </reference>
  <results_reference>
    <citation>West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.</citation>
    <PMID>22882836</PMID>
  </results_reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vector control</keyword>
  <keyword>LLIN</keyword>
  <keyword>IRS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 4, 2014</submitted>
    <returned>July 3, 2014</returned>
  </pending_results>
  <!-- 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/NCT01697852
org study id: ITDCVP54
nct id: NCT01697852
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The study is a cluster randomised trial to compare the effectiveness of indoor residual
      spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the
      effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary
      outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years,
      measured in cross sectional surveys. Secondary outcomes include relative population density
      for each mosquito vector species, malaria transmission as measured by entomological
      inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers
      including kdr, and user acceptability of LLINs compared with IRS.

      Findings from this study are expected to inform decision making so that resource utilization
      can be optimised.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Prevalence of malarial infection in children 6 months to 10 years
time frame: 9 months post randomisation
measure: Moderate to severe anaemia in children under 5 years
time frame: 9 months post randomisation
measure: Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years
time frame: 6 months post randomisation
measure: Entomological Innoculation Rate
time frame: Malaria season post randomisation(Average value during 6 months after randomisation)
measure: Relative abundance of adult Anopheles mosquitoes by species
time frame: Malaria season post randomisation (Average value during 6 months after randomisation)
measure: genotypic markers of insecticide resistance in malaria vector mosquitoes
time frame: Malaria season post randomisation (Average value during 6 months after randomisation)
arm group label: LLIN plus IRS
arm group type: Experimental
description: LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide
arm group label: LLIN only
arm group type: Active Comparator
description: LLIN by universal coverage campaign
intervention type: Other
intervention name: Indoor residual spraying with bendiocarb
description: 2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart
arm group label: LLIN plus IRS
other name: Ficam
intervention type: Other
intervention name: LLIN by universal coverage campaign
description: Long lasting Insecticide treated mosquito net
arm group label: LLIN only
arm group label: LLIN plus IRS
other name: Olyset nets
criteria: 
gender: All
minimum age: 6 Months
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Rowland, PHD
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
last name: Immo Kleinschmidt, PHD
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
last name: Mark Rowland, PHD
email: Mark.Rowland@lshtm.ac.uk
last name: Immo Kleinschmidt, PHD
email: Immo.Kleinschmidt@lshtm.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: Tanzania
citation: Kleinschmidt I, Schwabe C, Shiva M, Segura JL, Sima V, Mabunda SJ, Coleman M. Combining indoor residual spraying and insecticide-treated net interventions. Am J Trop Med Hyg. 2009 Sep;81(3):519-24.
PMID: 19706925
citation: West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.
PMID: 22882836
responsible party type: Sponsor
mesh term: Malaria
submitted: June 4, 2014
returned: July 3, 2014