Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 10 for:    Pyrethrins

Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02458066
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Medical Care Development, Inc.

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.

Condition or disease Intervention/treatment Phase
Malaria Other: IRS: bendiocarb Other: IRS: deltamethrin Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Bendiocarb
IRS: bendiocarb
Other: IRS: bendiocarb
carbamate insecticide
Other Name: FICAM

Active Comparator: Deltamethrin
IRS: deltamethrin
Other: IRS: deltamethrin
Pyrethroid insecticide
Other Name: K-Othrine SC 62.5




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Layout table for additonal information
Responsible Party: Medical Care Development, Inc.
ClinicalTrials.gov Identifier: NCT02458066     History of Changes
Other Study ID Numbers: MedicalCareDev
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases