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Insecticide Resistance Management in Burkina Faso and Côte d'Ivoire (REACT)

Primary Purpose

Malaria

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Insecticidal paint
Larvicide
Ivermectin
IEC
Sponsored by
Institut de Recherche pour le Developpement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria

Eligibility Criteria

6 Months - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be an inhabitant of the villages included into the RCT
  • Aged from 6month old to 20 years old

Exclusion Criteria:

  • older than 20 year old

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    insecticidal paint

    Larvicides

    Ivermectin

    Information, Education, Communication

    Arm Description

    No intervention

    The insecticidal paint contains two organophosphates, chlorpyriphos(1.5%) and diazinon (1.5%), and an insect growth regulator (IGR),pyriproxyfen (0.063%), as active ingredients.

    The larvicide is a slow release formulation containing Bacillus thuringiensis Var Israelensis.

    This arm consists in an injectable dose of Ivermectin given to peri-domestic animals.

    After a sociological study during the pre-intervention year, this arm will consist in a reinforced communication strategy relative to the nationwide current one

    Outcomes

    Primary Outcome Measures

    Malaria incidence
    Malaria cases reported in local health system

    Secondary Outcome Measures

    Entomological Inoculation Rate
    Number of infectious bites/personn
    Malaria prevalence
    % of positive blood smears among the population between 6 months to 20 years

    Full Information

    First Posted
    November 4, 2016
    Last Updated
    March 8, 2017
    Sponsor
    Institut de Recherche pour le Developpement
    Collaborators
    Institut de Recherche en Sciences de la Sante, Burkina Faso, Institut Pierre Richet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03074435
    Brief Title
    Insecticide Resistance Management in Burkina Faso and Côte d'Ivoire
    Acronym
    REACT
    Official Title
    Insecticide Resistance Management in Burkina Faso and Côte d'Ivoire: Research on Vector Control Strategies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Institut de Recherche pour le Developpement
    Collaborators
    Institut de Recherche en Sciences de la Sante, Burkina Faso, Institut Pierre Richet

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the benefit to use 1) insecticidal paints, 2) larvicides, 3) Ivermectin for both human and domestic animals and 4) strengthened Information, Education and Communication (IEC) strategy to complement the universal coverage with LLINs through a cluster randomized trial.
    Detailed Description
    Insecticidal paint comprised of two organophosphates (OPs) and an Insect Growth Regulator (IGR). This tool targets adult mosquitoes that are resistant pyrethroids to reduce vector density. Larvicide is a new formulation of Bacillus thuringiensis israelensis that will be implemented in major permanent breeding sites with the objective to reduce vector density. Ivermectin will be injected to domestic animals in addition to the national campaign implemented in the study area which treats the whole population. Ivermectin reduces the survival of mosquito that blood feed on treated humans and animals. Information, Education and Communication strategy aims to increase the adherence of the population to control tools available. Strengthening the IEC aims to increase the good use of long lasting nets.

    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
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Arm Title
    insecticidal paint
    Arm Type
    Experimental
    Arm Description
    The insecticidal paint contains two organophosphates, chlorpyriphos(1.5%) and diazinon (1.5%), and an insect growth regulator (IGR),pyriproxyfen (0.063%), as active ingredients.
    Arm Title
    Larvicides
    Arm Type
    Experimental
    Arm Description
    The larvicide is a slow release formulation containing Bacillus thuringiensis Var Israelensis.
    Arm Title
    Ivermectin
    Arm Type
    Experimental
    Arm Description
    This arm consists in an injectable dose of Ivermectin given to peri-domestic animals.
    Arm Title
    Information, Education, Communication
    Arm Type
    Experimental
    Arm Description
    After a sociological study during the pre-intervention year, this arm will consist in a reinforced communication strategy relative to the nationwide current one
    Intervention Type
    Device
    Intervention Name(s)
    Insecticidal paint
    Other Intervention Name(s)
    Inestfly 5A IGR
    Intervention Description
    Houses will be painted with insecticidal paint
    Intervention Type
    Device
    Intervention Name(s)
    Larvicide
    Intervention Description
    Larval breeding sites will be treated with larvicide
    Intervention Type
    Biological
    Intervention Name(s)
    Ivermectin
    Intervention Description
    Doses of Ivermectin will be injected to peri-domestic animals
    Intervention Type
    Behavioral
    Intervention Name(s)
    IEC
    Intervention Description
    A reinforced information, education and communication strategy will be implemented.
    Primary Outcome Measure Information:
    Title
    Malaria incidence
    Description
    Malaria cases reported in local health system
    Time Frame
    continuous monitoring during 2 years
    Secondary Outcome Measure Information:
    Title
    Entomological Inoculation Rate
    Description
    Number of infectious bites/personn
    Time Frame
    Every 8 weeks during 2 years
    Title
    Malaria prevalence
    Description
    % of positive blood smears among the population between 6 months to 20 years
    Time Frame
    Every 4 months during 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Must be an inhabitant of the villages included into the RCT Aged from 6month old to 20 years old Exclusion Criteria: older than 20 year old
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cédric Pennetier, PhD
    Organizational Affiliation
    Institut de Rehcerche pour le Développement
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Insecticide Resistance Management in Burkina Faso and Côte d'Ivoire

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