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Impact of Indoor Residual Spraying on Aedes-borne Diseases

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ClinicalTrials.gov Identifier: NCT04343521
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Gonzalo Vazquez-Prokopec, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aedes-borne Diseases Dengue Chikungunya Zika Biological: Targeted Indoor Residual Spraying (TIRS) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases
Actual Study Start Date : November 3, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Targeted Indoor Residual Spraying (TIRS)
All households in Targeted Indoor Residual Spraying (TIRS) clusters will be offered the intervention, epidemiological and entomological evaluation will occur in the center of each cluster
Biological: Targeted Indoor Residual Spraying (TIRS)
Spraying of insecticide Actellic 300CS will start May-June and extend for 1-2 months. Residents will be asked to temporarily leave the house during treatment and wait 0.5-1 h for the product to dry before re-entering the house. Insecticide application will follow strict protocol developed in CDC-Emory-UADY collaboration.
Other Name: Actellic 300CS

No Intervention: Control
Routine Aedes-borne virus (ABV) prevention and control, no Targeted Indoor Residual Spraying (TIRS)



Primary Outcome Measures :
  1. Number of laboratory confirmed (RT-PCR or IgM/IgG ELISA) symptomatic Aedes-borne Viruses in paired acute and convalescent samples [ Time Frame: Up to 5 years ]
    Number of laboratory confirmed (RT-PCR or IgM/IgG ELISA) symptomatic Aedes-borne Viruses (DENV, CHIKV and ZIKV) in paired acute and convalescent samples


Secondary Outcome Measures :
  1. Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses cases in annual surveillance samples [ Time Frame: Up to 5 years ]
    Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses (DENV, CHIKV and ZIKV) in annual surveillance samples

  2. Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) [ Time Frame: Up to 5 years ]
    Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) assessed by RT-PCR

  3. Ae. aegypti indoor entomological index adult presence/abundance [ Time Frame: Up to 5 years ]
    Ae. aegypti indoor entomological index adult presence/abundance will be calculated. Presence of mosquitoes/house. The higher the value, the worst the outcome.

  4. Ae. aegypti indoor entomological index female presence/abundance [ Time Frame: Up to 5 years ]
    Ae. aegypti indoor entomological index female presence/abundance will be calculated. Number of mosquitoes/house. The higher the value, the worst the outcome.

  5. Ae. aegypti indoor entomological index bloodfed female presence/abundance. Number of bloodfed females per house. The higher the value, the works the outcome. [ Time Frame: Up to 5 years ]
    Ae. aegypti indoor entomological index bloodfed female presence/abundance will be calculated



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.

Exclusion Criteria:

  1. 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 7d a week outside the home).Inability for a resident to provide informed consent.
    • Non-residential places (e.g., businesses, schools, markets, etc.).
  2. Individual Level Exclusion Criteria:

    • 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.
    • Having a medical condition that prevents implementation of study procedures.
    • Temporary visitor to household
    • Plans to leave study area within next 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343521


Contacts
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Contact: Gonzalo Vazquez Prokopec, PhD 404-727-4217 gmvazqu@emory.edu
Contact: Oscar D Kirstein, PhD odkirstein@emory.edu

Locations
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Mexico
Universidad Autonoma de Yucatan Recruiting
Merida, Yucatan, Mexico, 97203
Contact: Pablo Manrique-Saide, PhD    404-727-4217    pablo_manrique2000@hotmail.com   
Contact: Norma Pavia-Ruz, MD       norma_pavia_ruz@hotmail.com   
Sponsors and Collaborators
Emory University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Gonzalo Vazquez Prokopec, MD Emory University
Additional Information:
Publications:
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Responsible Party: Gonzalo Vazquez-Prokopec, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT04343521    
Other Study ID Numbers: IRB00108666
1U01AI148069-01 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, and appendices), will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Starting one year following conclusion of the trial. No end date.
Access Criteria: Investigators who provide a methodologically sound proposal will get access to achieve aims in the approved proposal. Proposals should be directed to lwaller@emory.edu. To gain access, data requesters will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gonzalo Vazquez-Prokopec, Emory University:
Targeted Indoor Residual Spraying
Children
DENV
CHIKV
ZIKV
Ae. aegypti mosquito