Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458066
• Other study ID #: MedicalCareDev
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: May 28, 2015
• Start date: February 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Medical Care Development, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Equatorial Guinea: Ministry of Health and Social Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2800
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Other:
• IRS: bendiocarb
carbamate insecticide
• IRS: deltamethrin
Pyrethroid insecticide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical Care Development, Inc.	London School of Hygiene and Tropical Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-5 months post receiving IRS	No
Secondary	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.	3-5 months post receiving IRS	No
Secondary	Severe anemia in children under 5	- Severe anaemia prevalence (haemoglobin< 8 g/dL) in children under 5 years of age of the participating localities.	3-5 months post receiving IRS	No