Applying Wolbachia to Eliminate Dengue (AWED)
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ClinicalTrials.gov Identifier: NCT03055585 |
Recruitment Status :
Terminated
(Distancing and movement restrictions of the COVID-19 emergency response made continuation of clinic-based and field entomological trial activities infeasible)
First Posted : February 16, 2017
Last Update Posted : June 9, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dengue Zika Virus Infection Chikungunya Fever | Biological: Wolbachia-infected Aedes aegypti mosquitoes Other: standard practice dengue control | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8173 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official 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 |
Actual Study Start Date : | November 8, 2017 |
Actual Primary Completion Date : | March 18, 2020 |
Actual Study Completion Date : | April 8, 2020 |

Arm | Intervention/treatment |
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Experimental: Intervention arm
Deployment of Wolbachia-infected Aedes aegypti mosquitoes
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Biological: Wolbachia-infected Aedes aegypti mosquitoes
Deployment of Wolbachia-infected Aedes aegypti mosquitoes Other: standard practice dengue control standard practice dengue control activities conducted by dengue control program |
Comparison arm
Standard practice dengue control activities
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Other: standard practice dengue control
standard practice dengue control activities conducted by dengue control program |
- Relative risk of dengue in Wolbachia-treated versus untreated clusters [ Time Frame: Up to 36 months participant enrolment ]Symptomatic, virologically-confirmed dengue virus (DENV) infection of any severity
- Relative risk of serotype-specific dengue in Wolbachia-treated versus untreated clusters [ Time Frame: Up to 36 months participant enrolment ]Symptomatic, virologically-confirmed serotype-specific DENV infection of any severity.
- Relative risk of Zika in Wolbachia-treated versus untreated clusters [ Time Frame: Up to 36 months participant enrolment ]Symptomatic, virologically-confirmed Zika virus (ZIKV) infection of any severity.
- Relative risk of Chikungunya in Wolbachia-treated versus untreated clusters [ Time Frame: Up to 36 months participant enrolment ]Symptomatic, virologically-confirmed Chikungunya virus (CHIKV) infection of any severity.

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Ages Eligible for Study: | 3 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055585
Indonesia | |
Faculty of Medicine, Universitas Gadjah Mada | |
Yogyakarta, DIY, Indonesia, 55281 |
Principal Investigator: | Adi Utarini, MD, PhD | Faculty of Medicine, Universitas Gadjah Mada |
Documents provided by Riris Andono Ahmad, Gadjah Mada University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Riris Andono Ahmad, Director of Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Gadjah Mada University |
ClinicalTrials.gov Identifier: | NCT03055585 |
Other Study ID Numbers: |
UGM_KE/FK/105/EC |
First Posted: | February 16, 2017 Key Record Dates |
Last Update Posted: | June 9, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Wolbachia; Ae. aegypti; Indonesia; Dengue; Cluster-randomised trial |
Dengue Chikungunya Fever Zika Virus Infection Virus Diseases Infections Arbovirus Infections Vector Borne Diseases |
Flavivirus Infections Flaviviridae Infections RNA Virus Infections Hemorrhagic Fevers, Viral Alphavirus Infections Togaviridae Infections |