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Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria

Cluster Randomised Trial to Compare Effectiveness of Bendiocarb and Deltamethrin (Long-Lasting) in Preventing Malaria Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02458066
Enrollment
2800
Registered
2015-05-29
Start date
2014-02-28
Completion date
2014-10-31
Last updated
2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

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.

Interventions

OTHERIRS: bendiocarb

carbamate insecticide

OTHERIRS: deltamethrin

Pyrethroid insecticide

Sponsors

London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Medical Care Development, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of falciparum infection in 2-14 year olds3-5 months post receiving IRSCross 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

MeasureTime frameDescription
Prevalence of infection, adjusted for potential cofounders in 2-14 year olds3-5 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 53-5 months post receiving IRS\- Severe anaemia prevalence (haemoglobin\< 8 g/dL) in children under 5 years of age of the participating localities.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026