Spatial Repellents for Arbovirus Control

NCT03553277 | Completed DMC

• 1 other identifier: 18-01-4370
• Study Type: interventional
• Target: 18,240
• Locations: 1 country
• Sites: 1

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.

Conditions

Arbovirus Infections

Keywords

Dengue; Zika; Chikungunya; Spatial repellent; transfluthrin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  2 years

• Adult female Aedes aegypti indoor abundance.

  2 years

• Adult female Aedes aegypti blood fed abundance.

  2 years

• Adult female Aedes aegypti parity rate.

  2 years

• Perception of product efficacy.

  2 years

Study Arms (2)

Transfluthrin

EXPERIMENTAL

transfluthrin

Other: transfluthrin

Placebo

PLACEBO COMPARATOR

inert ingredients

Other: placebo

Interventions

transfluthrin OTHER

passive emanator with formulated transfluthrin

Transfluthrin

placebo OTHER

passive emanator with formulated inert ingredients

Placebo

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• \< 2 years of age
• temporary visitor to household
• plans to leave study area within next 12 months
• FEBRILE SURVEILLANCE Household Level
• 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.
• 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
• 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)
• \<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

Sponsors & Collaborators

• University of Notre Dame: lead
• University of California, Davis: collaborator

Study Sites (1)

University of California, Davis

Iquitos, Peru

Location

MeSH Terms

Conditions

Arbovirus Infections; Dengue; Zika Virus Infection; Chikungunya Fever

Interventions

transfluthrin

Condition Hierarchy (Ancestors)

Vector Borne Diseases; Infections; Virus Diseases; Mosquito-Borne Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: June 12, 2018
• Study Start: June 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

PE (1)