Dengue Clinical Trial
— AWEDOfficial 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
Verified date | June 2020 |
Source | Gadjah Mada University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This cluster randomised trial will evaluate the efficacy of Wolbachia-infected Aedes aegytpi mosquitoes in reducing dengue cases in Yogyakarta City, Indonesia
Status | Terminated |
Enrollment | 8173 |
Est. completion date | April 8, 2020 |
Est. primary completion date | March 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Faculty of Medicine, Universitas Gadjah Mada | Yogyakarta | DIY |
Lead Sponsor | Collaborator |
---|---|
Gadjah Mada University | Monash University, The Tahija Foundation |
Indonesia,
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* Note: There are 63 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Relative risk of serotype-specific dengue in Wolbachia-treated versus untreated clusters | Symptomatic, virologically-confirmed serotype-specific DENV infection of any severity. | Up to 36 months participant enrolment | |
Secondary | Relative risk of Zika in Wolbachia-treated versus untreated clusters | Symptomatic, virologically-confirmed Zika virus (ZIKV) infection of any severity. | Up to 36 months participant enrolment | |
Secondary | Relative risk of Chikungunya in Wolbachia-treated versus untreated clusters | Symptomatic, virologically-confirmed Chikungunya virus (CHIKV) infection of any severity. | Up to 36 months participant enrolment |
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