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

Dengue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04343521
• Other study ID #: IRB00108666
• Secondary ID: 1U01AI148069-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 3, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4702
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Aedes-borne Diseases
• Chikungunya
• Dengue
• Zika

Intervention

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.

Locations

Country	Name	City	State
Mexico	Universidad Autonoma de Yucatan	Merida	Yucatan

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of laboratory confirmed (RT-PCR or IgM/IgG ELISA) symptomatic Aedes-borne Viruses in paired acute and convalescent samples living in the core 3x3 city blocks of each cluster.	Number of laboratory confirmed (RT-PCR or IgM/IgG ELISA) symptomatic Aedes-borne Viruses (DENV, CHIKV and ZIKV) in paired acute and convalescent samples for a subset of children living in the core 3x3 city blocks of the cluster.	Up to 5 years
Secondary	Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses cases in annual surveillance samples	Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses (DENV, CHIKV and ZIKV) in annual surveillance samples	Up to 5 years
Secondary	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 RT-PCR	Up to 5 years
Secondary	Ae. aegypti indoor entomological index adult presence/abundance	Ae. aegypti indoor entomological index adult presence/abundance will be calculated. Presence of mosquitoes/house. The higher the value, the worst the outcome.	Up to 5 years
Secondary	Ae. aegypti indoor entomological index female presence/abundance	Ae. aegypti indoor entomological index female presence/abundance will be calculated. Number of mosquitoes/house. The higher the value, the worst the outcome.	Up to 5 years
Secondary	Ae. aegypti indoor entomological index bloodfed female presence/abundance. Number of bloodfed females per house. The higher the value, the works the outcome.	Ae. aegypti indoor entomological index bloodfed female presence/abundance will be calculated	Up to 5 years
Secondary	Number of laboratory confirmed (RT-PCR or IgM/IgG ELISA) symptomatic Aedes-borne Viruses in paired acute and convalescent samples living in the entire cluster.	Number of laboratory confirmed (RT-PCR or IgM/IgG ELISA) symptomatic Aedes-borne Viruses (DENV, CHIKV and ZIKV) in paired acute and convalescent samples for a subset of children living in the entire cluster.	Up to 5 years

External Links

•   link to project website