Spatial Repellents for Arbovirus Control

Arbovirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553277
• Other study ID #: 18-01-4370
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18240
• Est. completion date: March 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Exclusion Criteria:

• households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile)

• sites where no residents spend time during the day (i.e., work 7d a week outside the home)

FEBRILE SURVEILLANCE Individual Level

Inclusion Criteria:

• individual who spends a minimum of 4 hours per week within the household

• = 2 years of age

• fever at the time of presentation or report of feverishness within the previous 24 hours or presenting with a rash, arthralgia, arthritis or non-purulent conjunctivitis (suspicion of Zika determined by project physician)

Exclusion Criteria:

• <2 years of age

• individuals who have spent less than 4 hours in the household during the week prior to illness

ENTOMOLOGICAL MONITORING Household Level

Inclusion Criteria:

• adult head of households agrees to survey

Exclusion Criteria:

• properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile)

SPATIAL REPELLENT INTERVENTION Household Level

Inclusion Criteria:

• adult head of households agrees to intervention deployment and to provide access to team member at 2-3 week intervals to change product

Exclusion Criteria:

• properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile)

Related Conditions & MeSH terms

• Arbovirus Infections

Intervention

Other:
• transfluthrin
passive emanator with formulated transfluthrin
• placebo
passive emanator with formulated inert ingredients

Locations

Country	Name	City	State
Peru	University of California, Davis	Iquitos

Sponsors (2)

Lead Sponsor	Collaborator
University of Notre Dame	University of California, Davis

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Aedes-borne virus (ABV) infection.	Compare 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.	2 years
Secondary	Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease.	Compare 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.	2 years
Secondary	Adult female Aedes aegypti indoor abundance.	Compare 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.	2 years
Secondary	Adult female Aedes aegypti blood fed abundance.	Compare 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.	2 years
Secondary	Adult female Aedes aegypti parity rate.	Compare 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.	2 years
Secondary	Perception of product efficacy.	Compare perceived efficacy of the product to reduce mosquito nuisance in households with active and placebo product as an indicator for product acceptability.	2 years