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Spatial Repellents for Arbovirus Control

Spatial Repellent Products for Control of Vector-borne Diseases - Dengue

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03553277
Enrollment
18240
Registered
2018-06-12
Start date
2015-06-30
Completion date
2019-03-31
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arbovirus Infections

Keywords

Dengue, Zika, Chikungunya, Spatial repellent, transfluthrin

Brief 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.

Detailed 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.

Interventions

passive emanator with formulated transfluthrin

OTHERplacebo

passive emanator with formulated inert ingredients

Sponsors

University of California, Davis
CollaboratorOTHER
University of Notre Dame
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

LONGITUDINAL SEROCONVERSION Individual Level Inclusion Criteria: * ≥ 2 years of age * plans to stay in study area for minimum of 12 months * resident of household or frequent visitor (\ 20% of day hours in house/mo)

Exclusion criteria

* \< 2 years of age * temporary visitor to household * plans to leave study area within next 12 months FEBRILE SURVEILLANCE Household Level Inclusion Criteria: * adult head of households agree to health visits and census * individuals spend a minimum of 4hrs per week during the daytime hours or sleep in the house. Temporary residents can be included.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Aedes-borne virus (ABV) infection.2 yearsCompare laboratory confirmed Aedes-borne dengue, Zika virus seroconversion rates in subjects residing in households with active and placebo product, receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator for ABV infections.

Secondary

MeasureTime frameDescription
Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease.2 yearsCompare laboratory confirmed Aedes-borne dengue, Zika virus infection rates in subjects residing in households with active and placebo product, receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator for ABV disease.
Adult female Aedes aegypti indoor abundance.2 yearsCompare adult female Aedes aegypti indoor abundance in households with active and placebo product as an indicator for reduced mosquito house entry due to effect of product.
Adult female Aedes aegypti blood fed abundance.2 yearsCompare adult female Aedes aegypti blood fed abundance in households with active and placebo product as an indicator for reduced mosquito human contact due to effect of product.
Adult female Aedes aegypti parity rate.2 yearsCompare adult female Aedes aegypti parity rates in households with active and placebo product as an indicator for reduced mosquito survival due to effect of product.
Perception of product efficacy.2 yearsCompare perceived efficacy of the product to reduce mosquito nuisance in households with active and placebo product as an indicator for product acceptability.

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026