Applying Wolbachia to Eliminate Dengue

NCT03055585 | Terminated DMC

• 1 other identifier: UGM_KE/FK/105/EC
• Study Type: interventional
• Target: 8,173
• Locations: 1 country
• Sites: 1

Brief Summary

This cluster randomised trial will evaluate the efficacy of Wolbachia-infected Aedes aegytpi mosquitoes in reducing dengue cases in Yogyakarta City, Indonesia

Conditions

Dengue; Zika Virus Infection; Chikungunya Fever

Keywords

Wolbachia; Ae. aegypti; Indonesia; Dengue; Cluster-randomised trial

Outcome Measures

Primary Outcomes (1)

• Relative risk of dengue in Wolbachia-treated versus untreated clusters

  Symptomatic, virologically-confirmed dengue virus (DENV) infection of any severity

  Up to 36 months participant enrolment

Secondary Outcomes (3)

• Relative risk of serotype-specific dengue in Wolbachia-treated versus untreated clusters

  Up to 36 months participant enrolment

• Relative risk of Zika in Wolbachia-treated versus untreated clusters

  Up to 36 months participant enrolment

• Relative risk of Chikungunya in Wolbachia-treated versus untreated clusters

  Up to 36 months participant enrolment

Study Arms (2)

Intervention arm

EXPERIMENTAL

Deployment of Wolbachia-infected Aedes aegypti mosquitoes

Biological: Wolbachia-infected Aedes aegypti mosquitoes; Other: standard practice dengue control

Comparison arm

OTHER

Standard practice dengue control activities

Other: standard practice dengue control

Interventions

Wolbachia-infected Aedes aegypti mosquitoes BIOLOGICAL

Deployment of Wolbachia-infected Aedes aegypti mosquitoes

Intervention arm

standard practice dengue control OTHER

standard practice dengue control activities conducted by dengue control program

Comparison arm; Intervention arm

Eligibility Criteria

• Age: 3 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fever (either self-reported or objectively measured, e.g. (tympanic membrane temperature ≥38oC)) of 1-4 days duration, and where onset was prior to the day of presentation
• Aged between 3-45 years old
• Resided in the study area every night for the 10 days preceding illness onset

You may not qualify if:

• Localising features suggestive of a specific diagnosis other than an arboviral infection e.g. severe diarrhea, otitis, pneumonia
• Prior enrollment in the study within the previous 4 weeks

Sponsors & Collaborators

• Gadjah Mada University: lead
• Monash University: collaborator
• The Tahija Foundation: collaborator

Study Sites (1)

Faculty of Medicine, Universitas Gadjah Mada

Yogyakarta, DIY, 55281, Indonesia

Location

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MeSH Terms

Conditions

Dengue; Zika Virus Infection; Chikungunya Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections

Study Officials

• Adi Utarini, MD, PhD

  Faculty of Medicine, Universitas Gadjah Mada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: November 8, 2017
• Primary Completion: March 18, 2020
• Study Completion: April 8, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

ID (1)