NCT02458066

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

May 13, 2015

Last Update Submit

May 28, 2015

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Prevalence of infection, adjusted for potential cofounders in 2-14 year olds

    3-5 months post receiving IRS

  • Severe anemia in children under 5

    3-5 months post receiving IRS

Study Arms (2)

Bendiocarb

ACTIVE COMPARATOR

IRS: bendiocarb

Other: IRS: bendiocarb

Deltamethrin

ACTIVE COMPARATOR

IRS: deltamethrin

Other: IRS: deltamethrin

Interventions

IRS: bendiocarbOTHER

carbamate insecticide

Also known as: FICAM
Bendiocarb
IRS: deltamethrinOTHER

Pyrethroid insecticide

Also known as: K-Othrine SC 62.5
Deltamethrin

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Areas with historically high rates of refusing IRS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malaria

Interventions

bendiocarb

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 29, 2015

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

May 29, 2015

Record last verified: 2015-05