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Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IRS: bendiocarb
IRS: deltamethrin
Sponsored by
Medical Care Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria

Eligibility Criteria

2 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children between 2-14 years old who reside in a household within the intervention area
  • Household clusters chosen among those with historically high IRS acceptance rate
  • Household clusters chosen to maximize distance between clusters.

Exclusion Criteria:

  • Areas with historically high rates of refusing IRS

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Bendiocarb

    Deltamethrin

    Arm Description

    IRS: bendiocarb

    IRS: deltamethrin

    Outcomes

    Primary Outcome Measures

    Prevalence of falciparum infection in 2-14 year olds
    Cross sectional Rapid Diagnostic Test (RDT)-based prevalence of infection of P.falciparum in children between the ages of 2 and 14 of the participating localities.

    Secondary Outcome Measures

    Prevalence of infection, adjusted for potential cofounders in 2-14 year olds
    - RDT-based prevalence of infection in children between the ages of 2 and 14 of the participating localities, adjusted for potential confounders, such as bednet use, socio-economic status, age of subjects etc.
    Severe anemia in children under 5
    - Severe anaemia prevalence (haemoglobin< 8 g/dL) in children under 5 years of age of the participating localities.

    Full Information

    First Posted
    May 13, 2015
    Last Updated
    May 28, 2015
    Sponsor
    Medical Care Development, Inc.
    Collaborators
    London School of Hygiene and Tropical Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02458066
    Brief Title
    Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria
    Official Title
    Cluster Randomised Trial to Compare Effectiveness of Bendiocarb and Deltamethrin (Long-Lasting) in Preventing Malaria Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical Care Development, Inc.
    Collaborators
    London School of Hygiene and Tropical Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout Bioko Island to be sprayed with either a long lasting pyrethroid insecticide, K-Othrine SC 62.5, or a bendiocarb insecticide, FICAM. Parasite prevalence in children aged 2-14 was measured before and after the application of insecticide.
    Detailed Description
    In 2013, a new long lasting pyrethroid insecticide, K-Othrine SC 62.5, that has been developed by Bayer AG, was used for the IRS program in Bioko Island, Equatorial Guinea, for the first time. This change coincided with a marked increase in parasite prevalence in 2-14 year olds as measured in the Annual Malaria Indicator Survey (14% to 28%, respectively). In order to determine whether the change in insecticide caused the increase in prevalence, a cluster randomized control trial was designed. Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout Bioko Island. Clusters were chosen with an attempt to maximize the geographical space between clusters (to minimize possible residual effects from insecticides), while ensuring that areas with historically higher acceptance rates for Indoor Residual Spraying (IRS) were selected. Each cluster had a buffer zone of 300m (or halfway between clusters less than 600m apart). A team of 10 local surveyors conducted a baseline survey in each cluster area, measuring prevalence through malaria Rapid Diagnostic Test (RDT) positivity, net ownership, spray coverage, and hemoglobin levels. Approximately 100 children in each cluster were tested. These data were then used for a restricted randomization. Each cluster was then sprayed with either deltamethrin or bendiocarb, depending on randomization. The IRS team put equal amount of effort into each cluster, as determined by number of sprayers/house/day in an attempt to minimize bias. An end-line survey was conducted using an ODK Collect application in the same cluster areas. Prevalence was measured by RDT, and hemoglobin data was gathered. In addition, the head of household was asked about the acceptability to IRS and their willingness to receive the insecticide in a future round.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2800 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bendiocarb
    Arm Type
    Active Comparator
    Arm Description
    IRS: bendiocarb
    Arm Title
    Deltamethrin
    Arm Type
    Active Comparator
    Arm Description
    IRS: deltamethrin
    Intervention Type
    Other
    Intervention Name(s)
    IRS: bendiocarb
    Other Intervention Name(s)
    FICAM
    Intervention Description
    carbamate insecticide
    Intervention Type
    Other
    Intervention Name(s)
    IRS: deltamethrin
    Other Intervention Name(s)
    K-Othrine SC 62.5
    Intervention Description
    Pyrethroid insecticide
    Primary Outcome Measure Information:
    Title
    Prevalence of falciparum infection in 2-14 year olds
    Description
    Cross sectional Rapid Diagnostic Test (RDT)-based prevalence of infection of P.falciparum in children between the ages of 2 and 14 of the participating localities.
    Time Frame
    3-5 months post receiving IRS
    Secondary Outcome Measure Information:
    Title
    Prevalence of infection, adjusted for potential cofounders in 2-14 year olds
    Description
    - RDT-based prevalence of infection in children between the ages of 2 and 14 of the participating localities, adjusted for potential confounders, such as bednet use, socio-economic status, age of subjects etc.
    Time Frame
    3-5 months post receiving IRS
    Title
    Severe anemia in children under 5
    Description
    - Severe anaemia prevalence (haemoglobin< 8 g/dL) in children under 5 years of age of the participating localities.
    Time Frame
    3-5 months post receiving IRS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children between 2-14 years old who reside in a household within the intervention area Household clusters chosen among those with historically high IRS acceptance rate Household clusters chosen to maximize distance between clusters. Exclusion Criteria: Areas with historically high rates of refusing IRS

    12. IPD Sharing Statement

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    Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria

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