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
|Condition or disease||Intervention/treatment||Phase|
|Arbovirus Infections||Other: transfluthrin Other: placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15730 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
passive emanator with formulated transfluthrin
Placebo Comparator: Placebo
passive emanator with formulated inert ingredients
- 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.
- 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
- 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
- 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
- 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
- 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.
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
|University of California, Davis|