NCT06268691

Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating

Completed NA Last updated 13 May 2024

What this trial tests

NA trial testing Insecticide Coating INESFLY in Dengue in 35,000 participants. Completed in 31 July 2023.

Timeline

4 February 2019

Primary endpoint
2 September 2019

31 July 2023

Quick facts

Lead sponsor	Rocio Cardenas Sanchez
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	35,000
Start date	4 February 2019
Primary completion	2 September 2019
Estimated completion	31 July 2023
Sites	2 locations across Colombia, Germany

Drugs / interventions tested

• Insecticide Coating INESFLY

Conditions studied

• Dengue — all drugs for Dengue →
• Vector Borne Diseases — all drugs for Vector Borne Diseases →
• Arbovirus Infections — all drugs for Arbovirus Infections →
• Zika — all drugs for Zika →

Sponsor

Rocio Cardenas Sanchez

Who can join

Eligibility, any sex, with Dengue or Vector Borne Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.7%) in suspension, without interaction between them, development by INESFLY®, Spain.

The main questions it aims to answer are:

Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia.

Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti.

The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA.

The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm.

In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multi-omics insights into mosquito insecticide resistance for integrated vector management.
   Li J, Wang QY. · · 2026 · PMID 42038460 · DOI 10.7717/peerj.21083