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

NCT06268691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35000

Last updated 2024-05-13

No results posted yet for this study

Summary

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.

Conditions

  • Dengue
  • Vector Borne Diseases
  • Arbovirus Infections
  • Zika
  • Chikungunya Fever

Interventions

OTHER

Insecticide Coating INESFLY

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, developing by INESFLY Corporation, key achievement of the year 2017 TDR-WHO.

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER
  • Instituto Nacional de Salud, Colombia

    collaborator OTHER_GOV
  • Instituto Departamental de Salud de Norte de Santander

    collaborator UNKNOWN
  • Universidad Francisco de Paula de Santander

    collaborator UNKNOWN
  • Rocio Cardenas Sanchez

    lead OTHER

Principal Investigators

  • Axel Kroeger, Prof. Dr. · University of Freiburg, Centre for Medicine and Society

  • Rocio Cardenas, Research Dr. · University of Freiburg, Centre for Medicine and Society

  • Winfried Kern, Prof. Dr. · University of Freiburg

  • Max Petzold, Prof. Dr. · Institute of Public Health, Gothenburg University, Göteborg, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2019-09-02
Completion
2023-07-31

Countries

  • Colombia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268691 on ClinicalTrials.gov