NCT06268691

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2019

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

January 26, 2024

Last Update Submit

May 9, 2024

Conditions

DengueVector Borne DiseasesArbovirus InfectionsZikaChikungunya Fever

Keywords

novel microencapsulated formulationinsecticides

Outcome Measures

Primary Outcomes (1)

  • Change of dengue incidence for 12 months

    the dengue incidence for the year 2021 is compared with the incidence for the year 2022 in the study clusters, according to the control or intervention condition. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA, Norte de Santander, Colombia

    12 months

Secondary Outcomes (1)

  • Change of vector densities estimated through larval and pupal indices.

    9 months

Study Arms (2)

Control arm

NO INTERVENTION

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

Intervention arm

EXPERIMENTAL

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

Other: Insecticide Coating INESFLY

Interventions

Insecticide Coating INESFLYOTHER

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.

Also known as: Coating of microencapsulated insecticides
Intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Dwellings located within the intervention arm
  • Dwellings are inhabited
  • Dwellings have a washing-tank

You may not qualify if:

  • Dwellings that do not have washing-tanks
  • Dwellings have a water tank with biological control -fish-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Departamental de Salud de Norte de Santander

Cúcuta, Norte de Santander Department, 540001, Colombia

Location

Centre for Medicine and Society

Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany

Location

Related Publications (5)

  • Carrillo MA, Cardenas R, Yanez J, Petzold M, Kroeger A. Risk of dengue, Zika, and chikungunya transmission in the metropolitan area of Cucuta, Colombia: cross-sectional analysis, baseline for a cluster-randomised controlled trial of a novel vector tool for water containers. BMC Public Health. 2023 May 30;23(1):1000. doi: 10.1186/s12889-023-15893-4.

    PMID: 37254133RESULT

  • Carrillo MA, Kroeger A, Cardenas Sanchez R, Diaz Monsalve S, Runge-Ranzinger S. The use of mobile phones for the prevention and control of arboviral diseases: a scoping review. BMC Public Health. 2021 Jan 9;21(1):110. doi: 10.1186/s12889-020-10126-4.

    PMID: 33422034RESULT

  • Cardenas R, Hussain-Alkhateeb L, Benitez-Valladares D, Sanchez-Tejeda G, Kroeger A. The Early Warning and Response System (EWARS-TDR) for dengue outbreaks: can it also be applied to chikungunya and Zika outbreak warning? BMC Infect Dis. 2022 Mar 7;22(1):235. doi: 10.1186/s12879-022-07197-6.

    PMID: 35255839RESULT

  • Wright E, Carrillo MA, Matamoros D, Sanchez RC, Yanez J, Di Lorenzo G, Villa JM, Kroeger A. Applicability of the Mexican ovitrap system for Aedes vector surveillance in Colombia. Pathog Glob Health. 2023 Sep;117(6):554-564. doi: 10.1080/20477724.2022.2146049. Epub 2022 Nov 16.

    PMID: 36384430RESULT

  • Hussain-Alkhateeb L, Rivera Ramirez T, Kroeger A, Gozzer E, Runge-Ranzinger S. Early warning systems (EWSs) for chikungunya, dengue, malaria, yellow fever, and Zika outbreaks: What is the evidence? A scoping review. PLoS Negl Trop Dis. 2021 Sep 16;15(9):e0009686. doi: 10.1371/journal.pntd.0009686. eCollection 2021 Sep.

    PMID: 34529649RESULT

MeSH Terms

Conditions

DengueVector Borne DiseasesArbovirus InfectionsZika Virus InfectionChikungunya Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesInfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralAlphavirus InfectionsTogaviridae Infections

Study Officials

  • Axel Kroeger, Prof. Dr.

    University of Freiburg, Centre for Medicine and Society

    STUDY DIRECTOR

  • Rocio Cardenas, Research Dr.

    University of Freiburg, Centre for Medicine and Society

    PRINCIPAL INVESTIGATOR

  • Winfried Kern, Prof. Dr.

    University of Freiburg

    STUDY CHAIR

  • Max Petzold, Prof. Dr.

    Institute of Public Health, Gothenburg University, Göteborg, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A cluster randomised trial for the application of a new vector control tool (insecticide coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. Each cluster comprising approximately 2,000 dwellings.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 20, 2024

Study Start

February 4, 2019

Primary Completion

September 2, 2019

Study Completion

July 31, 2023

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

IPD related to cluster results will be partially shared in the publications resulting from the study. Data may be requested with justification from the ZMG UNI-FRIEBURG researchers- data committee. Partially available at https://doi.org/10.1186/s12889-023-15893-4

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
up to 12 months after publication.
Access Criteria
the unit of the study is the dwelling, therefore data surveyed in dwellings, without individual addresses, will be available as supplementary material within the publications. Further data may be requested from the corresponding author up to 12 months after publication.

Locations

CO(1)DE(1)