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Aedes-borne DiseasesNCT04343521

Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases

A study testing Targeted Indoor Residual Spraying (TIRS) in people with Aedes-borne Diseases and Dengue, run by Emory University at 1 site in Mexico.

Completed

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

Official record
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Trial summary

The objective of this trial is evaluate the efficacy of Targeted Indoor Residual Spraying (TIRS) in preventing symptomatic disease caused by Aedes-borne diseases (ABDs) in children 2 to 15 years of age in the city of Merida, Yucatan State, Mexico. Read more about this study

Who is it for?
Ages 2 to 15 years
Conditions the study is for
Aedes-borne Diseases, Dengue, Chikungunya
What is being tested?
Targeted Indoor Residual Spraying (TIRS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,461 participants
Where
1 siteMexico
Study dates
3 Nov 2020to 28 Apr 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Household Level Inclusion Criteria:
  • Household is located within the bounds of a study cluster (5x5 city-block clusters)
  • City block has at least 60% premises that are residential
  • Individual Level Inclusion Criteria:
  • 2 or more and up to 15 years of age at the time of initial enrollment
  • Living in a house that consented to TIRS (for children in TIRS cluster)

Who cannot join

  • Household Level 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 7days a week outside the home)
  • Inability for a resident to provide informed consent
  • Non-residential places (e.g., businesses, schools, markets, etc.)
  • Individual Level Exclusion Criteria:
Show all 11Show fewer
  • Less than 2 years of age or more than 15 years of age at the time of enrollment
  • Not living in a house that consented to TIRS (for children in TIRS cluster)
  • Having a medical condition that prevents implementation of study procedures
  • Temporary visitor to household
  • Plans to leave study area within next 12 months

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Universidad Autonoma de Yucatan

    Mérida, Yucatán, 97203

Other trials in Mexico

About this study

The objective of this trial is evaluate the efficacy of Targeted Indoor Residual Spraying (TIRS) in preventing symptomatic disease caused by Aedes-borne diseases (ABDs) in children 2 to 15 years of age in the city of Merida, Yucatan State, Mexico.

Read the detailed description

Contemporaneous urban vector control (truck-mounted ultra-low volume spraying, thermal fogging, larviciding) has failed to contain dengue epidemics and to prevent the global range expansion of Aedes-borne diseases (ABDs: dengue, chikungunya, zika). Part of the challenge in sustaining effective ABD control emerges from the remarkable paucity of evidence about the epidemiological impact of any vector control method. Furthermore, the classic deployment of interventions in response to clinical cases fails to account for the important contribution of out-of-home human mobility and asymptomatic infections.

The trial will be conducted in the city of Merida extending ongoing longitudinal cohort to follow a population of 4,600 children 2-15 years old randomly allocated to receive either TIRS treatment or not. If efficacious, TIRS will drive a paradigm shift in Aedes control by: considering Ae. aegypti behavior to rationally guide insecticide applications; the change to preventive control (pre- ABD transmission season rather than in response to symptomatic cases); the use of third generation insecticides to which Ae. Aegypti is susceptible.

Being tested
Targeted Indoor Residual Spraying (TIRS)
Keywords
Targeted Indoor Residual Spraying, Children, Dengue virus (DENV), Chikungunya virus (CHIKV), Zika virus (ZIKV), Ae. aegypti mosquito
Medical subject headings
Mosquito-Borne Diseases, Dengue, Chikungunya Fever, Zika Virus Infection

What participants receive

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

  • Targeted Indoor Residual Spraying (TIRS)Other

    Also called Actellic 300CS

    Spraying of insecticide Actellic 300CS will start in May or June extending for 1 to 2 months. Residents will be asked to temporarily leave the house during treatment and wait half an hour to one hour for the product to dry before re-entering the house. Insecticide application will follow strict protocol developed by the Centers for Disease Control and Prevention (CDC), Emory University, and the Universidad Autónoma de Yucatán.

Study groups in NCT04343521
Study groupRoleWhat they receive
Targeted Indoor Residual Spraying (TIRS)ExperimentalAll households in Targeted Indoor Residual Spraying (TIRS) clusters will be offered the intervention, and children in households that consent to TIRS will be recruited into this study arm.
Receives: Other: Targeted Indoor Residual Spraying (TIRS)
Routine Aedes-borne Virus (ABV) Prevention and ControlNo interventionHouseholds in the control clusters receive routine Aedes-borne virus (ABV) prevention and control, without Targeted Indoor Residual Spraying (TIRS). Children in the control households will be recruited into this study arm.

What is being measured

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

  1. Number of Symptomatic Participants Testing Positive for Aedes-borne Virus Infections That Are Laboratory Confirmed or Serologically

    The number of symptomatic children with laboratory confirmed, by reverse transcription-polymerase chain reaction (RT-PCR) or immunoglobulin M/ immunoglobulin G (IgM/IgG) enzyme-linked immunosorbent assay (ELISA), Aedes-borne Viruses infections. The number of any Aedes-borne virus infection during three seasons of high transmission is described, as well as the number of Dengue virus (DENV), Chikungunya virus (CHIKV), Zika virus (ZIKV) and coinfections.

    Measured: 18 months of active surveillance during high transmission seasons (each 6 months in duration) during 3 years (July through December in 2021, 2022, and 2023)

Secondary outcomes (7)
  1. Number Positive Tests of Laboratory Confirmed Aedes-borne Viruses Infections By Season

    Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses (DENV, CHIKV and ZIKV) in annual surveillance samples.

    Measured: Up to 36 months, during serosurvey seasons 2021-2022, 2022-2023, and 2023-2024

  2. Ae. Aegypti Mosquito Infection Rate With Aedes-borne Viruses (DENV, CHIKV and ZIKV)

    Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) assessed by the number of positive RT-PCR tests. Infection is mosquitoes is analyzed by collecting binary data (a mosquito pool is either infected or not) and transforming that into minimum infection rates (MIR) with the calculation: (1/number of mosquitoes in the pool) times 1000. Households were randomly selected for testing; houses were eligible for testing if they were located within the central blocks and had at least one child enrolled in the study.

    Measured: Up to 6 months (mosquito pools were collected during the 6 months post TIRS spraying samplings in 2021)

  3. Ae. Aegypti Indoor Entomological Index of Adult Mosquito Abundance

    The Ae. aegypti indoor entomological index of adult mosquito presence/abundance is calculated as the number of adult mosquitoes per house. Higher values mean that more mosquitoes are found within houses.

    Measured: Up to 36 months starting at the first TIRS application

  4. Ae. Aegypti Indoor Entomological Index of Female Mosquito Abundance

    The Ae. aegypti indoor entomological index of female mosquito presence/abundance is calculated as the number of female mosquitoes per house. Higher values mean that more mosquitoes are found within houses.

    Measured: Up to 36 months starting at first TIRS application

  5. Ae. Aegypti Indoor Entomological Index of Bloodfed Female Mosquito Abundance

    The Ae. aegypti indoor entomological index of bloodfed female mosquito presence/abundance is calculated as the number of bloodfed female mosquitoes per house. Higher values mean that more mosquitoes are found within houses.

    Measured: Up to 36 months starting at first TIRS application

  6. Number of Households Where the Head of Household Would Recommend the Intervention

    Acceptability of the intervention is determined through household surveys, for households that received the intervention. Acceptability is assessed as the number of households where the head of that household would recommend the intervention to others.

    Measured: Post-intervention (up to 41 months and 26 days after the start of the intervention)

  7. Number of Households With a Resident That Had a Reaction to the Insecticide

    Safety of the intervention is assessed as the number of households receiving the TIRS intervention that had evidence of a household resident having a reaction possibly related to the insecticide, which was assessed and confirmed by study doctors.

    Measured: Post-intervention (up to 41 months and 26 days after the start of the intervention)

Timeline

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

  1. First posted13 Apr 2020
  2. Study start3 Nov 2020
  3. Primary completion28 Apr 2024
  4. Study completion28 Apr 2024

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
None (open label)
Enrolment
4,461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04343521
Sponsor's protocol ID
IRB00108666
Other IDs
1U01AI148069-01
Status last verified
Aug 2025
First submitted
9 Apr 2020
Last updated
18 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data that underlie the results reported in publications of this study will be available for sharing with other researchers.

Publications

  • Manrique-Saide P, Dean NE, Halloran ME, Longini IM, Collins MH, Waller LA, Gomez-Dantes H, Lenhart A, Hladish TJ, Che-Mendoza A, Kirstein OD, Romer Y, Correa-Morales F, Palacio-Vargas J, Mendez-Vales R, Perez PG, Pavia-Ruz N, Ayora-Talavera G, Vazquez-Prokopec GM. The TIRS trial: protocol for a cluster randomized controlled trial assessing the efficacy of preventive targeted indoor residual spraying to reduce Aedes-borne viral illnesses in Merida, Mexico. Trials. 2020 Oct 8;21(1):839. doi: 10.1186/s13063-020-04780-7.

    PubMed 33032661
  • Che-Mendoza A, Gonzalez-Olvera G, Medina-Barreiro A, Arisqueta-Chable C, Bibiano-Marin W, Correa-Morales F, Kirstein OD, Manrique-Saide P, Vazquez-Prokopec GM. Efficacy of targeted indoor residual spraying with the pyrrole insecticide chlorfenapyr against pyrethroid-resistant Aedes aegypti. PLoS Negl Trop Dis. 2021 Oct 4;15(10):e0009822. doi: 10.1371/journal.pntd.0009822. eCollection 2021 Oct.

    PubMed 34606519
  • Dzul-Manzanilla F, Correa-Morales F, Che-Mendoza A, Palacio-Vargas J, Sanchez-Tejeda G, Gonzalez-Roldan JF, Lopez-Gatell H, Flores-Suarez AE, Gomez-Dantes H, Coelho GE, da Silva Bezerra HS, Pavia-Ruz N, Lenhart A, Manrique-Saide P, Vazquez-Prokopec GM. Identifying urban hotspots of dengue, chikungunya, and Zika transmission in Mexico to support risk stratification efforts: a spatial analysis. Lancet Planet Health. 2021 May;5(5):e277-e285. doi: 10.1016/S2542-5196(21)00030-9.

    PubMed 33964237
  • Kirstein OD, Ayora-Talavera G, Koyoc-Cardena E, Chan Espinoza D, Che-Mendoza A, Cohuo-Rodriguez A, Granja-Perez P, Puerta-Guardo H, Pavia-Ruz N, Dunbar MW, Manrique-Saide P, Vazquez-Prokopec GM. Natural arbovirus infection rate and detectability of indoor female Aedes aegypti from Merida, Yucatan, Mexico. PLoS Negl Trop Dis. 2021 Jan 4;15(1):e0008972. doi: 10.1371/journal.pntd.0008972. eCollection 2021 Jan.

    PubMed 33395435
  • Dzib-Florez S, Ponce-Garcia G, Medina-Barreiro A, Gonzalez-Olvera G, Contreras-Perera Y, Del Castillo-Centeno F, Ahmed AMM, Che-Mendoza A, McCall PJ, Vazquez-Prokopec G, Manrique-Saide P. Evaluating Over-the-Counter Household Insecticide Aerosols for Rapid Vector Control of Pyrethroid-Resistant Aedes aegypti. Am J Trop Med Hyg. 2020 Nov;103(5):2108-2112. doi: 10.4269/ajtmh.20-0515.

    PubMed 32748782
  • Dean NE, Crisp AM, Che-Mendoza A, Kirstein OD, Barrera-Fuentes GA, Earnest JT, Puerta-Guardo HN, Collins MH, Pavia-Ruz N, Ayora-Talavera G, Gonzalez-Olvera G, Medina-Barreiro A, Bibiano-Marin W, Jabbarzadeh S, Halloran ME, Longini IM Jr, Lenhart A, Waller LA, Correa-Morales F, Palacio-Vargas J, Gomez-Dantes H, Manrique-Saide P, Vazquez-Prokopec GM. Randomized Trial of Targeted Indoor Spraying to Prevent Aedes-Borne Diseases. N Engl J Med. 2025 Oct 9;393(14):1387-1398. doi: 10.1056/NEJMoa2501069.

    PubMed 41061233

Questions about this trial

What is this clinical trial studying?

A study testing Targeted Indoor Residual Spraying (TIRS) in people with Aedes-borne Diseases and Dengue, run by Emory University at 1 site in Mexico.

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 6 inclusion and 11 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 18 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 1 site in Mexico. 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. 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?

Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Symptomatic Participants Testing Positive for Aedes-borne Virus Infections That Are Laboratory Confirmed or Serologically (time frame: 18 months of active surveillance during high transmission seasons (each 6 months in duration) during 3 years (July through December in 2021, 2022, and 2023)). 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 NCT04343521, which also lists 6 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 18 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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