Applying Wolbachia to Eliminate Dengue

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03055585
• Date of registration: 14/02/2017
• Prospective Registration: Yes
• Primary sponsor: Gadjah Mada University
• Public title: Applying Wolbachia to Eliminate Dengue AWED
• Scientific title: Applying Wolbachia to Eliminate Dengue (AWED): A Non-blinded Cluster Randomised Controlled Trial to Assess the Efficacy of Wolbachia-infected Mosquito Deployments to Reduce Dengue Incidence in Yogyakarta, Indonesia
• Date of first enrolment: November 8, 2017
• Target sample size: 8173
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03055585
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Adi Utarini, MD, PhD
• Affiliation: Faculty of Medicine, Universitas Gadjah Mada

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 3 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dengue

Zika Virus Infection

Chikungunya Fever

Intervention(s)

Biological: Wolbachia-infected Aedes aegypti mosquitoes

Other: standard practice dengue control

Primary Outcome(s)

Relative risk of dengue in Wolbachia-treated versus untreated clusters [Time Frame: Up to 36 months participant enrolment]

Secondary Outcome(s)

Relative risk of serotype-specific dengue in Wolbachia-treated versus untreated clusters [Time Frame: Up to 36 months participant enrolment]

Relative risk of Zika in Wolbachia-treated versus untreated clusters [Time Frame: Up to 36 months participant enrolment]

Relative risk of Chikungunya in Wolbachia-treated versus untreated clusters [Time Frame: Up to 36 months participant enrolment]

Secondary ID(s)

UGM_KE/FK/105/EC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Tahija Foundation

Monash University