Arbovirus InfectionsNCT03553277
Spatial Repellents for Arbovirus Control
A study testing transfluthrin in people with Arbovirus Infections, run by University of Notre Dame at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arbovirus Infections
- What is being tested?
- transfluthrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18,240 participants
- Where
- 1 sitePeru
- Study dates
- Jun 2015to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥ 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)
- 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.
- individual who spends a minimum of 4 hours per week within the household
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- ≥ 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)
- adult head of households agrees to survey
- adult head of households agrees to intervention deployment and to provide access to team member at 2-3 week intervals to change product
Who cannot join
- < 2 years of age
- temporary visitor to household
- plans to leave study area within next 12 months
- FEBRILE SURVEILLANCE Household Level
- 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)
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- FEBRILE SURVEILLANCE Individual Level
- <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
- 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
- properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spatial Repellent Products for Control of Vector-borne Diseases - Dengue
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.
Read the 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.
- Conditions
- Arbovirus Infections
- Being tested
- transfluthrin, placebo
- Keywords
- Dengue, Zika, Chikungunya, Spatial repellent, transfluthrin
- Medical subject headings
- Arbovirus Infections, Dengue, Zika Virus Infection, Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transfluthrinOther
passive emanator with formulated transfluthrin
placeboOther
passive emanator with formulated inert ingredients
| Study group | Role | What they receive |
|---|---|---|
| Transfluthrin | Experimental | transfluthrin Receives: Other: transfluthrin |
| Placebo | Placebo comparator | inert ingredients Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease.
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.
Measured: 2 years
Adult female Aedes aegypti indoor abundance.
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.
Measured: 2 years
Adult female Aedes aegypti blood fed abundance.
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.
Measured: 2 years
Adult female Aedes aegypti parity rate.
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.
Measured: 2 years
Perception of product efficacy.
Compare perceived efficacy of the product to reduce mosquito nuisance in households with active and placebo product as an indicator for product acceptability.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study startJun 2015
- Primary completionNov 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553277
- Sponsor's protocol ID
- 18-01-4370
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2018
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Repellent Products for Control of Vector-borne Diseases - Dengue
- ClinicalTrials.gov ID
- NCT03553277
- Acronym / sponsor ID
- 18-01-4370
- Conditions
- Arbovirus Infections
- Keywords
- Dengue, Zika, Chikungunya, Spatial repellent, transfluthrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,240 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Jun 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfluthrin | Experimental | Other: transfluthrintransfluthrin |
| Placebo | Placebo comparator | Other: placeboinert ingredients |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 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)
- 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.
Key exclusion criteria (13 listed)
- < 2 years of age
- temporary visitor to household
- plans to leave study area within next 12 months
- FEBRILE SURVEILLANCE Household Level
- households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transfluthrinpassive emanator with formulated transfluthrin | Other | Transfluthrin |
| placebopassive emanator with formulated inert ingredients | Other | Placebo |
Primary outcome
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.
5 secondary outcomes
Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease.
Time frame: 2 years
Adult female Aedes aegypti indoor abundance.
Time frame: 2 years
Adult female Aedes aegypti blood fed abundance.
Time frame: 2 years
Adult female Aedes aegypti parity rate.
Time frame: 2 years
Perception of product efficacy.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transfluthrin in people with Arbovirus Infections, run by University of Notre Dame at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Aedes-borne virus (ABV) infection. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.