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

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ClinicalTrials.gov Identifier: NCT03074435
Recruitment Status : Unknown
Verified March 2017 by Cédric PENNETIER, Institut de Recherche pour le Developpement.
Recruitment status was:  Enrolling by invitation
First Posted : March 8, 2017
Last Update Posted : March 10, 2017
Sponsor:
Collaborators:
Institut de Recherche en Sciences de la Sante, Burkina Faso
Institut Pierre Richet
Information provided by (Responsible Party):
Cédric PENNETIER, Institut de Recherche pour le Developpement

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malaria Device: Insecticidal paint Device: Larvicide Biological: Ivermectin Behavioral: IEC Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Insecticide Resistance Management in Burkina Faso and Côte d'Ivoire: Research on Vector Control Strategies
Study Start Date : April 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
Drug Information available for: Ivermectin

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
No intervention
Experimental: insecticidal paint
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.
 Device: Insecticidal paint
Houses will be painted with insecticidal paint
Other Name: Inestfly 5A IGR
Experimental: Larvicides
The larvicide is a slow release formulation containing Bacillus thuringiensis Var Israelensis.
 Device: Larvicide
Larval breeding sites will be treated with larvicide
Experimental: Ivermectin
This arm consists in an injectable dose of Ivermectin given to peri-domestic animals.
 Biological: Ivermectin
Doses of Ivermectin will be injected to peri-domestic animals
Experimental: Information, Education, Communication
After a sociological study during the pre-intervention year, this arm will consist in a reinforced communication strategy relative to the nationwide current one
 Behavioral: IEC
A reinforced information, education and communication strategy will be implemented.


Outcome Measures
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Primary Outcome Measures :
  1. Malaria incidence [ Time Frame: continuous monitoring during 2 years ]
    Malaria cases reported in local health system


Secondary Outcome Measures :
  1. Entomological Inoculation Rate [ Time Frame: Every 8 weeks during 2 years ]
    Number of infectious bites/personn

  2. Malaria prevalence [ Time Frame: Every 4 months during 2 years ]
    % of positive blood smears among the population between 6 months to 20 years


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074435


Sponsors and Collaborators
Institut de Recherche pour le Developpement
Institut de Recherche en Sciences de la Sante, Burkina Faso
Institut Pierre Richet
Investigators
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Principal Investigator: Cédric Pennetier, PhD Institut de Rehcerche pour le Développement
More Information
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Responsible Party: Cédric PENNETIER, Principal Investigator, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT03074435    
Other Study ID Numbers: InstitutRD
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
 Vector Borne Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents