Skip to main content
OpenTrials
Completed

NCT Number: NCT02458066

Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IRS: bendiocarb

Other

carbamate insecticide

Other names: FICAM

IRS: deltamethrin

Other

Pyrethroid insecticide

Other names: K-Othrine SC 62.5

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Medical Care Development, Inc.

Other

Collaborators

  • London School of Hygiene and Tropical Medicine

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 29, 2015
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.