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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03074435
Other study ID # InstitutRD
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received November 4, 2016
Last updated March 8, 2017
Start date April 2016
Est. completion date April 2019

Study information

Verified date March 2017
Source Institut de Recherche pour le Developpement
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 18000
Est. completion date April 2019
Est. primary completion date October 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 20 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Insecticidal paint
Houses will be painted with insecticidal paint
Larvicide
Larval breeding sites will be treated with larvicide
Biological:
Ivermectin
Doses of Ivermectin will be injected to peri-domestic animals
Behavioral:
IEC
A reinforced information, education and communication strategy will be implemented.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Institut de Recherche pour le Developpement Institut de Recherche en Sciences de la Sante, Burkina Faso, Institut Pierre Richet

Outcome

Type Measure Description Time frame Safety issue
Primary Malaria incidence Malaria cases reported in local health system continuous monitoring during 2 years
Secondary Entomological Inoculation Rate Number of infectious bites/personn Every 8 weeks during 2 years
Secondary Malaria prevalence % of positive blood smears among the population between 6 months to 20 years Every 4 months during 2 years
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