Spatial Repellents for Arbovirus Control
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|ClinicalTrials.gov Identifier: NCT03553277|
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : March 5, 2021
|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 :||18240 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 :||November 2018|
|Actual Study Completion Date :||March 2019|
passive emanator with formulated transfluthrin
Placebo Comparator: Placebo
passive emanator with formulated inert ingredients
- Incidence of Aedes-borne virus (ABV) infection. [ Time Frame: 2 years ]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.
- Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease. [ Time Frame: 2 years ]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. [ Time Frame: 2 years ]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. [ Time Frame: 2 years ]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. [ Time Frame: 2 years ]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. [ Time Frame: 2 years ]Compare perceived efficacy of the product to reduce mosquito nuisance in households with active and placebo product as an indicator for product acceptability.
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|