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Spatial Repellents for Arbovirus Control

Primary Purpose

Arbovirus Infections

Status

Completed

Phase

Not Applicable

Locations

Peru

Study Type

Interventional

Intervention

transfluthrin

placebo

About this trial

This is an interventional other trial for Arbovirus Infections focused on measuring Dengue, Zika, Chikungunya, Spatial repellent, transfluthrin

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transfluthrin

Placebo

Arm Description

transfluthrin

inert ingredients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03553277

First Posted

January 23, 2018

Last Updated

March 3, 2021

Sponsor

University of Notre Dame

Collaborators

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT03553277

Brief Title

Spatial Repellents for Arbovirus Control

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

November 2018 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Notre Dame

Collaborators

University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arbovirus Infections

Keywords

Dengue, Zika, Chikungunya, Spatial repellent, transfluthrin

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transfluthrin

Arm Type

Experimental

Arm Description

transfluthrin

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

inert ingredients

Intervention Type

Other

Intervention Name(s)

transfluthrin

Intervention Description

passive emanator with formulated transfluthrin

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

passive emanator with formulated inert ingredients

Primary Outcome Measure Information:

Title

Incidence of Aedes-borne virus (ABV) infection.

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease.

Description

Time Frame

2 years

Title

Adult female Aedes aegypti indoor abundance.

Description

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.

Time Frame

2 years

Title

Adult female Aedes aegypti blood fed abundance.

Description

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.

Time Frame

2 years

Title

Adult female Aedes aegypti parity rate.

Description

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.

Time Frame

2 years

Title

Perception of product efficacy.

Description

Compare perceived efficacy of the product to reduce mosquito nuisance in households with active and placebo product as an indicator for product acceptability.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility 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. 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)

Facility Information:

Facility Name

University of California, Davis

City

Iquitos

Country

Peru

12. IPD Sharing Statement

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Spatial Repellents for Arbovirus Control

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