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Spatial Repellents for Arbovirus Control

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ClinicalTrials.gov Identifier: NCT03553277
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
University of Notre Dame

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.

Condition or disease Intervention/treatment Phase
Arbovirus Infections Other: transfluthrin Other: placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15730 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Spatial Repellent Products for Control of Vector-borne Diseases - Dengue
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: Transfluthrin
transfluthrin
Other: transfluthrin
passive emanator with formulated transfluthrin

Placebo Comparator: Placebo
inert ingredients
Other: placebo
passive emanator with formulated inert ingredients




Primary Outcome Measures :
  1. Incidence of DCZV infections [ Time Frame: 2 years ]
    Compare incidence of DCZV infections in subjects residing in households with active and placebo product, receiving standard entomological surveillance and control procedures by the local ministry of health.


Secondary Outcome Measures :
  1. Aedes spp. pupal density [ Time Frame: 2 years ]
    Compare Aedes spp. pupal densities in households with active and placebo product as indicator for reduced mosquito egg-laying due to the product

  2. Aedes spp. adult density [ Time Frame: 2 years ]
    Compare Aedes spp. indoor:outdoor adult densities in households with active and placebo product as indicator for reduced mosquito house entry due to effect of product

  3. Aedes spp. female blood fed density [ Time Frame: 2 years ]
    Compare Aedes spp. blood fed female densities in households with active and placebo product as indicator for reduced mosquito human contact due to effect of product

  4. Aedes spp. female parous density [ Time Frame: 2 years ]
    Compare Aedes spp. female parous densities in households with active and placebo product as indicator for reduced mosquito survival due to effect of product

  5. Perception of product efficacy [ Time Frame: 2 years ]
    Compare perceived efficacy of product to reduce mosquito nuisance in households with active and placebo product as indicator for product acceptability. Scale ranges from 0 (no difference in mosquito nuisance from before product was installed), 1 (less mosquito nuisance then before the product was installed) and 2 (greater mosquito nuisance since the product has been installed). A value of 1 is considered the better outcome whereas a value of 2 is considered the worse outcome. Scores will be averaged for each treatment arm.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553277


Locations
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Peru
University of California, Davis
Iquitos, Peru
Sponsors and Collaborators
University of Notre Dame
University of California, Davis

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Responsible Party: University of Notre Dame
ClinicalTrials.gov Identifier: NCT03553277     History of Changes
Other Study ID Numbers: 18-01-4370
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Notre Dame:
Dengue
Zika
Chikungunya
Spatial repellent
transfluthrin

Additional relevant MeSH terms:
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Arbovirus Infections
Virus Diseases