- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553277
Spatial Repellents for Arbovirus Control
Spatial Repellent Products for Control of Vector-borne Diseases - Dengue
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Iquitos, Peru
- University of California, Davis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Transfluthrin
transfluthrin
|
passive emanator with formulated transfluthrin
|
PLACEBO_COMPARATOR: Placebo
inert ingredients
|
passive emanator with formulated inert ingredients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
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.
|
2 years
|
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.
|
2 years
|
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.
|
2 years
|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-01-4370
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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