Spatial Repellents for Aedes-borne Virus Control in Sri Lanka

NCT05452447 | Completed DMC

• 1 other identifier: 21-05-6629
• Study Type: interventional
• Target: 6,949
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of a single SR product, in reducing DENV infection and active Aedes-borne virus (ABV) disease in human cohorts. The study design will be a prospective, cluster randomized controlled trial (cRCT). Although not a specific objective of this project, an overall goal is to allow for official recommendations (or not) from the World Health Organization (WHO) for the use of SRs in public health. A WHO global policy recommendation will establish evaluation systems of SR products to regulate efficacy evaluations, thereby increasing quality, overall use and a consequent reduction in disease.

Conditions

Arbovirus Infections

Keywords

Dengue; Zika; Chikungunya; Spatial Repellent; Transfluthrin; Vector-borne diseases; Mosquito vectors; Incidence

Outcome Measures

Primary Outcomes (1)

• Incidence of Aedes-borne virus (ABV) infection in the 'longitudinal cohort'.

  The primary endpoint is the fraction of monotypic or seronegative individuals in the 'longitudinal cohort' who seroconvert to an arbovirus during the follow-up period post randomization with intervention. Here, the intervention follow-up period is 2 years after initial deployment of SR or placebo. There will be 3 blood samplings from longitudinal cohort participants for measure of seroconversion: one for baseline serostatus characterization (T0), a second at 12 months (T1) and a third at 24 months (T2) from time of initial placement of intervention.

  24 months

Secondary Outcomes (5)

• Clinically apparent cases of Aedes-borne virus (ABV) disease.

  24 months

• Adult female Aedes aegypti indoor abundance.

  24 months

• Adult female Aedes aegypti blood fed rate.

  24 months

• Diversion of Aedes aegypti mosquitoes into untreated houses.

  24 months

• Overall incidence of Aedes-borne virus (ABV) infection.

  24 months

Other Outcomes (5)

• Adverse Events (AEs) and Serious Adverse Events (SAEs).

  24 months

• Incidence of Aedes-borne virus (ABV) infection in subjects residing in households within treatment clusters but without SR product.

  24 months

• Clinically apparent cases of Aedes-borne virus (ABV) disease in subjects residing in households within treatment clusters but without SR product.

  24 months

Study Arms (2)

Spatial Repellent

EXPERIMENTAL

Transfluthrin

Device: Transfluthrin

Placebo

PLACEBO COMPARATOR

Inert ingredients

Device: Placebo

Interventions

Transfluthrin DEVICE

Passive emanator with formulated transfluthrin

Spatial Repellent

Placebo DEVICE

Passive emanator with formulated inert ingredients

Placebo

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 4 - 16 years of age
• Plans to stay in residence and/or study area for a minimum of 24 months
• Resident of household or frequent visitor (\~20% of day hours in house / month)

You may not qualify if:

• \< 4 and \> 16 years of age
• Plans to leave residence and/or study area within next 24 months
• Temporary visitor to household (\<20% of day hours in house/ month)
• FEBRILE SURVEILLANCE Household Level
• Adult head of households agrees to census, health visits and logging resident symptoms when febrile (or in the case of suspected Zika in the absence of fever, presenting with rash, arthralgia, arthritis or non-purulent conjunctivitis).
• Individuals spend a minimum of 4hrs per week during the daytime hours or sleep in the house.
• Adult head of households does not agree to census, health visits or logging symptoms of residents.
• 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
• ≥ 6mo 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)
• Individual who spends a minimum of 4 hours per week within the household or sleeps in the house.
• \< 6mo of age.
• No fever at time of presentation or report of feverishness within the previous 24 hours or not reporting with a rash, arthralgia, arthritis or non-purulent conjunctivitis

Sponsors & Collaborators

• University of Notre Dame: lead
• S.C. Johnson & Son, Inc.: collaborator
• fhiClinical: collaborator
• Ministry of Health, Sri Lanka: collaborator
• University of Sri Jayewardenepura, Sri Lanka: collaborator
• University of Washington: collaborator
• RemediumOne: collaborator

Study Sites (2)

Epidemiology Unit, Ministry of Health

Colombo, West, 00100, Sri Lanka

Location

Clinical Trials Unit

Ragama, West, 01010, Sri Lanka

Location

Related Publications (36)

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MeSH Terms

Conditions

Arbovirus Infections; Dengue; Zika Virus Infection; Chikungunya Fever; Vector Borne Diseases

Condition Hierarchy (Ancestors)

Infections; Virus Diseases; Mosquito-Borne Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections

Study Officials

• John P Grieco, Ph.D.

  University of Notre Dame

  STUDY DIRECTOR

• Korelege Hasitha Aravinda Tissera, M.D.

  Epidemiology Unit, Ministry of Health, Sri Lanka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: March 2, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data and supporting information will be made available 12 months following completion of data analysis and will remain open access in the public domain.
• Access Criteria: Open-access repository distributed under the terms of the Creative Commons Attribution (CC-BY) License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Locations

SR (2)