Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03553277 |
Other study ID # |
18-01-4370 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 2015 |
Est. completion date |
March 2019 |
Study information
Verified date |
March 2021 |
Source |
University of Notre Dame |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Dengue viruses are the most medically important arthropod-borne pathogens worldwide, with
transmission occurring in most tropical and sub-tropical regions. An estimated 390 million
infections occur yearly. Although, there are considerable ongoing efforts to develop a
vaccine, vector control remains the only option for reducing dengue virus (DENV) transmission
and disease burden. The recent emergence of Aedes-borne Zika (ZIKV) and Chikungunya viruses
(CHIKV) highlight need for novel vector control tools. The goal of this project is to
determine the efficacy of a spatial repellent (SR) product (active ingredient transfluthrin)
for reducing contact between household residents and vector mosquitos and as a result reduce
DENV, ZIKV, and/or other Aedes-borne virus transmission. Henceforth the investigators will
designate the combined risk of Aedes-borne dengue, Chikungunya, Zika virus transmission by
(DCZV). Spatial repellency is used here as a general term to refer to a range of insect
behaviors caused by airborne chemicals that reduce contact between people and disease
vectors. This can include movement away from a chemical stimulus, and interference with host
detection (attraction-inhibition) and/or feeding response.
Description:
Protection provided by this product will be measured using entomological and virological
approaches, comparing entomological indices will be measured through standard household
monitoring of Aedes aegypti population densities, while DCZV transmission will be measured
through door-to-door surveillance for active dengue disease and through serological
monitoring for DCZV exposure in a randomized cluster trial.
The investigators will establish a cohort of 3,400 persons, primarily children 2-12 years of
age and adults who have not been previously infected with DCZV who will provide annual blood
samples when they are healthy (longitudinal cohort), whereas in the same clusters the
investigators expect to monitor up to 27,500 residents for active dengue disease (febrile
surveillance cohort). The cohort will be monitored for a period of 2 years. The use of
spatial repellents has never been tested on a large scale to reduce disease and could change
vector control practices worldwide, reducing the amount of chemical insecticides applied and
also prevent the development of insecticide resistance. The investigators plan to implement a
short questionnaire to determine levels of acceptability and perceived efficacy amongst
participating households.
The project will be carried out in the Amazonia City of Iquitos, Peru, which has a
well-established infrastructure for studying urban dengue fever. The study will generate
rigorous evidence, documenting and evaluating the impact of SR products on human infection
rates, to be considered and used by academia, industry and public health key stakeholders at
the global, regional, national and/or local level and drive efforts to acquire full
recommendation of SR products for inclusion in disease control programs.