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
About this trial
This is an interventional prevention trial for Malaria
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
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
NCT ID
NCT02458066
First Posted
May 13, 2015
Last Updated
May 28, 2015
Sponsor
Medical Care Development, Inc.
Collaborators
London School of Hygiene and Tropical Medicine
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
Learn more about this trial
Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria
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