AzTrials
AzTrials

Arbovirus InfectionsAEGIS ABVNCT05452447

Spatial Repellents for Aedes-borne Virus Control in Sri Lanka

A study testing Transfluthrin in people with Arbovirus Infections, run by University of Notre Dame at 2 sites in Sri Lanka.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for
Arbovirus Infections
What is being tested?
Transfluthrin
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,949 participants
Where
2 sitesSri Lanka
Study dates
2 Mar 2023to 30 Jun 2025
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 6 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • ≥ 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)
  • 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.
  • ≥ 6mo of age.
Show all 12Show fewer
  • 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.
  • Adult head of household agrees to surveys.
  • Properties where study personnel do not identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
  • Adult head of households agrees to have intervention applied inside the home and to provide access to team member at 4-week intervals to change products.
  • Properties where study personnel do not identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).

Who cannot join

  • < 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 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).
Show all 17Show fewer
  • 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.
  • 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
  • Individuals who have spent less than 4 hours in the household during the week prior to illness.
  • ENTOMOLOGICAL MONITORING Household Level
  • Adult head of household does not agree to surveys.
  • 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
  • Adult head of household does not agree to Mosquito ShieldTM deployment or study team access.
  • 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

2 sites in 1 country.

Sri Lanka2 sites

  • Epidemiology Unit, Ministry of Health

    Colombo, West, 00100

  • Clinical Trials Unit

    Ragama, West, 01010

Other trials in Sri Lanka

About this study

Official title: A Cluster Randomized, Placebo Control Trial to Evaluate the Efficacy of a Spatial Repellent (Mosquito ShieldTM) Against Aedes-borne Virus Infection Among Children ≥ 4-16 Years of Age in the Gampaha District, Sri Lanka

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.

Read the detailed description

The study will be a prospective, cRCT, participant and observer-blinded, placebo-controlled trial in a site endemic for ABV to measure the impact of a SR product on new ABV virus infections. Clusters of households, each cluster containing 110-120 residents testing negative for antibodies against DENV (seronegative) or positive to a single DENV infection (monotypic), will be selected from three MOH areas in the district of Gampaha: Negambo, Wattala, Kelaniya. All participating houses in each cluster will be monitored entomologically for adult Aedes aegypti surveys for 3 months before deployment of the SR intervention and monthly after the intervention is in place. Entomological surveys will include monitoring of indoor Ae. aegypti adult population densities and blood-fed status. DENV infection in study participants will be assessed by serologic testing of scheduled longitudinal blood samples (primary outcome) and passively by monitoring febrile persons for acute Dengue illness (secondary outcome). Seroconversion to DENV from baseline (pre-intervention) and follow-up (post-intervention) samples as well as ABV active disease rates will be compared between active intervention and placebo (control) clusters. Testing and confirmation of Zika virus (ZIKV) and Chikungunya virus (CHIKV) infection at baseline and during the intervention phase of the trial will be dependent on circulation history/detection in study area during study period.

The spatial repellent (SR) will be a new formulation of transfluthrin. This active ingredient (AI) is widely used in mosquito coils and other household pest control products worldwide. The new formulation is a passive emanator that will release the AI over a period of up to four weeks, Mosquito ShieldTM. The emanator will consist of a pre-treated piece of cellulose acetate or other medium, which will be positioned within consenting households according to manufacturer specifications of 2 units/9m2. A placebo product of matched design with inert ingredients will be applied similarly. The Mosquito ShieldTM and placebo products for this study will be designed and provided by S.C. Johnson, INC. A Family Company.

Being tested
Transfluthrin, Placebo
Keywords
Dengue, Zika, Chikungunya, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence
Medical subject headings
Arbovirus Infections, Dengue, Zika Virus Infection, Chikungunya Fever, Vector Borne Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TransfluthrinDevice

    Passive emanator with formulated transfluthrin

  • PlaceboDevice

    Passive emanator with formulated inert ingredients

Study groups in NCT05452447
Study groupRoleWhat they receive
Spatial RepellentExperimentalTransfluthrin
Receives: Device: Transfluthrin
PlaceboPlacebo comparatorInert ingredients
Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (5)

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

    Clinically apparent is defined as an acute infection that causes overt symptoms (fever, rash, etc.) indicating virus circulation in the blood. For the longitudinal cohort participants, acute and convalescent blood sampling based on time of health facility visit when febrile throughout the intervention period. For other household members participating in febrile surveillance, case definition measured and reported whenever they visit designated health facilities throughout the intervention period.

    Measured: 24 months

  2. Adult female Aedes aegypti indoor abundance.

    Measured by comparing adult female Aedes aegypti indoor abundance in households using Procopak mosquito aspiration with active and placebo product receiving standard entomological surveillance and control procedures by the local Ministry of Health, as an indicator for reduced mosquito house entry due to effect of product. Indoor mosquito collections in enrolled households once every 28 days during intervention.

    Measured: 24 months

  3. Adult female Aedes aegypti blood fed rate.

    Measured by comparing adult female Aedes aegypti blood fed rate in households with active and placebo product receiving standard entomological surveillance and control procedures by the local Ministry of Health, as an indicator for reduced mosquito human contact due to effect of product. Direct mosquito abdominal observation by microscopy from samples taken by Procopak aspiration during indoor mosquito collections in enrolled households once every 28 days during intervention.

    Measured: 24 months

  4. Diversion of Aedes aegypti mosquitoes into untreated houses.

    Measured by comparing adult female Aedes aegypti abundance using Procopak mosquito aspiration in untreated households adjacent to treatment clusters (with active product) to untreated households adjacent to placebo clusters as an indicator for mosquito diversion due to effect of product. Indoor mosquito collections in enrolled households once every 28 days during intervention.

    Measured: 24 months

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

    Measured by the seroconversion rates of all children enrolled in the trial, independent of order of infection (i.e., including tertiary and quaternary infections). Based on blood samples taken for longitudinal seroconversion and febrile surveillance from time of initial placement of intervention.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start2 Mar 2023
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
6,949 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452447
Sponsor's protocol ID
21-05-6629
Acronym
AEGIS ABV
Status last verified
Sep 2025
First submitted
6 Jul 2022
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Analytical datasets will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.

Publications

  • Achee NL, Bangs MJ, Farlow R, Killeen GF, Lindsay S, Logan JG, Moore SJ, Rowland M, Sweeney K, Torr SJ, Zwiebel LJ, Grieco JP. Spatial repellents: from discovery and development to evidence-based validation. Malar J. 2012 May 14;11:164. doi: 10.1186/1475-2875-11-164.

    PubMed 22583679

  • Achee NL, Sardelis MR, Dusfour I, Chauhan KR, Grieco JP. Characterization of spatial repellent, contact irritant, and toxicant chemical actions of standard vector control compounds. J Am Mosq Control Assoc. 2009 Jun;25(2):156-67. doi: 10.2987/08-5831.1.

    PubMed 19653497

  • Ansari MZ, Shope RE, Malik S. Evaluation of vero cell lysate antigen for the ELISA of flaviviruses. J Clin Lab Anal. 1993;7(4):230-7. doi: 10.1002/jcla.1860070408.

    PubMed 8395596

  • Comach G, Blair PJ, Sierra G, Guzman D, Soler M, de Quintana MC, Bracho-Labadie M, Camacho D, Russell KL, Olson JG, Kochel TJ. Dengue virus infections in a cohort of schoolchildren from Maracay, Venezuela: a 2-year prospective study. Vector Borne Zoonotic Dis. 2009 Feb;9(1):87-92. doi: 10.1089/vbz.2007.0213. Epub 2008 Sep 12.

    PubMed 18788903

  • Forshey BM, Morrison AC, Cruz C, Rocha C, Vilcarromero S, Guevara C, Camacho DE, Alava A, Madrid C, Beingolea L, Suarez V, Comach G, Kochel TJ. Dengue virus serotype 4, northeastern Peru, 2008. Emerg Infect Dis. 2009 Nov;15(11):1815-8. doi: 10.3201/eid1511.090663.

    PubMed 19891873

  • Erlanger TE, Keiser J, Utzinger J. Effect of dengue vector control interventions on entomological parameters in developing countries: a systematic review and meta-analysis. Med Vet Entomol. 2008 Sep;22(3):203-21. doi: 10.1111/j.1365-2915.2008.00740.x.

    PubMed 18816269

  • Getis A, Morrison AC, Gray K, Scott TW. Characteristics of the spatial pattern of the dengue vector, Aedes aegypti, in Iquitos, Peru. Am J Trop Med Hyg. 2003 Nov;69(5):494-505.

    PubMed 14695086

  • Grieco JP, Achee NL, Chareonviriyaphap T, Suwonkerd W, Chauhan K, Sardelis MR, Roberts DR. A new classification system for the actions of IRS chemicals traditionally used for malaria control. PLoS One. 2007 Aug 8;2(8):e716. doi: 10.1371/journal.pone.0000716.

    PubMed 17684562

  • Grieco JP, Achee NL, Sardelis MR, Chauhan KR, Roberts DR. A novel high-throughput screening system to evaluate the behavioral response of adult mosquitoes to chemicals. J Am Mosq Control Assoc. 2005 Dec;21(4):404-11. doi: 10.2987/8756-971X(2006)21[404:ANHSST]2.0.CO;2.

    PubMed 16506566

  • Grieco JP, Achee NL, Andre RG, Roberts DR. A comparison study of house entering and exiting behavior of Anopheles vestitipennis (Diptera: Culicidae) using experimental huts sprayed with DDT or deltamethrin in the southern district of Toledo, Belize, C.A. J Vector Ecol. 2000 Jun;25(1):62-73.

    PubMed 10925798

  • Gubler DJ. Aedes aegypti and Aedes aegypti-borne disease control in the 1990s: top down or bottom up. Charles Franklin Craig Lecture. Am J Trop Med Hyg. 1989 Jun;40(6):571-8. doi: 10.4269/ajtmh.1989.40.571. No abstract available.

    PubMed 2472746

  • Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev. 1998 Jul;11(3):480-96. doi: 10.1128/CMR.11.3.480.

    PubMed 9665979

  • Gubler DJ. Epidemic dengue/dengue hemorrhagic fever as a public health, social and economic problem in the 21st century. Trends Microbiol. 2002 Feb;10(2):100-3. doi: 10.1016/s0966-842x(01)02288-0.

    PubMed 11827812

  • Hapuarachchi HA, Bandara KB, Hapugoda MD, Williams S, Abeyewickreme W. Laboratory confirmation of dengue and chikungunya co-infection. Ceylon Med J. 2008 Sep;53(3):104-5. doi: 10.4038/cmj.v53i3.252. No abstract available.

    PubMed 18982804

  • Hapuarachchi HC, Bandara KB, Sumanadasa SD, Hapugoda MD, Lai YL, Lee KS, Tan LK, Lin RT, Ng LF, Bucht G, Abeyewickreme W, Ng LC. Re-emergence of Chikungunya virus in South-east Asia: virological evidence from Sri Lanka and Singapore. J Gen Virol. 2010 Apr;91(Pt 4):1067-76. doi: 10.1099/vir.0.015743-0. Epub 2009 Dec 2.

    PubMed 19955565

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 2 sites in Sri Lanka.

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 12 inclusion and 17 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sri Lanka. 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 in the 'longitudinal cohort'. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05452447, which also lists 36 linked publications.

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 15 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in