Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria
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|ClinicalTrials.gov Identifier: NCT02458066|
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Other: IRS: bendiocarb Other: IRS: deltamethrin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cluster Randomised Trial to Compare Effectiveness of Bendiocarb and Deltamethrin (Long‐Lasting) in Preventing Malaria Infection|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||October 2014|
Active Comparator: Bendiocarb
Other: IRS: bendiocarb
Other Name: FICAM
Active Comparator: Deltamethrin
Other: IRS: deltamethrin
Other Name: K-Othrine SC 62.5
- Prevalence of falciparum infection in 2-14 year olds [ Time Frame: 3-5 months post receiving IRS ]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.
- Prevalence of infection, adjusted for potential cofounders in 2-14 year olds [ Time Frame: 3-5 months post receiving IRS ]- 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 [ Time Frame: 3-5 months post receiving IRS ]- Severe anaemia prevalence (haemoglobin< 8 g/dL) in children under 5 years of age of the participating localities.