Clinical Trial: Applying Wolbachia to Eliminate Dengue

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Non-blinded Cluster Randomised Controlled Trial to Assess the Efficacy of Wolbachia-infected Mosquito Deployments to Reduce Dengue Incidence in Yogyakarta, Indonesia

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

Detailed Summary:

Primary objective:

To assess the efficacy of community-based deployments of Wolbachia-infected Aedes aegypti mosquitoes in reducing the incidence of symptomatic, virologically-confirmed dengue cases of any severity in Yogyakarta residents aged 3-30 years in release areas, relative to non-release areas.

Secondary objectives:

  • To measure the efficacy of the Wolbachia method in reducing the incidence of symptomatic virologically confirmed Zika virus and chikungunya virus infection in release areas, relative to non-release areas
  • To quantify the level of human mobility within Yogyakarta City, and to estimate the degree to which this mobility reduces the power to measure the effect of a cluster-randomised intervention

Study setting:

The study will be conducted in Yogyakarta City and Bantul District, both located in the province of Yogyakarta Special Region, Indonesia.The study site is 26 km2 in size, including 24 km2 within Yogyakarta City, and 2km2 in the adjacent Bantul District. The total population of the study area is approximately 350,000.

Study design:

A cluster randomised trial with a test-negative design will be conducted. The study site will be divided into 24 clusters. The intervention will be allocated using constrained block randomisation with a parallel 1:1 assignment of intervention and control.

The intervention is the deployment of Wolbachia-infected Aedes aegypti mosquitoes. Wolbachia deployments will be conducted in intervention clusters with th
Sponsor: Gadjah Mada University

Current Primary Outcome: Dengue incidence rate ratio in Wolbachia-treated versus untreated clusters [ Time Frame: 24 months participant enrolment ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Zika incidence rate ratio in Wolbachia-treated versus untreated clusters [ Time Frame: 24 months participant enrolment ]
    Symptomatic, virologically-confirmed Zika virus (ZIKV) infection of any severity.
  • Chikungunya incidence rate ratio in Wolbachia-treated versus untreated clusters [ Time Frame: 24 months participant enrolment ]
    Symptomatic, virologically-confirmed Chikungunya virus (CHIKV) infection of any severity.


Original Secondary Outcome: Same as current

Information By: Gadjah Mada University

Dates:
Date Received: February 14, 2017
Date Started: March 2017
Date Completion: December 2019
Last Updated: March 26, 2017
Last Verified: March 2017