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Applying Wolbachia to Eliminate Dengue (AWED)

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ClinicalTrials.gov Identifier: NCT03055585
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : June 4, 2018
Sponsor:
Collaborators:
Monash University
The Tahija Foundation
Information provided by (Responsible Party):
Riris Andono Ahmad, Gadjah Mada University

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Intervention arm
Deployment of Wolbachia-infected Aedes aegypti mosquitoes
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
Other: standard practice dengue control
standard practice dengue control activities conducted by dengue control program




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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

Information from the National Library of Medicine

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


Contacts
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Contact: Riris A Ahmad, MD, PhD +62 274 547 147 riris.andono@eliminatedengue.com
Contact: Citra Indriani, MD, MPH +62 274 547 147 citra.indriani@eliminatedengue.com

Locations
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Indonesia
Faculty of Medicine, Universitas Gadjah Mada Recruiting
Yogyakarta, DIY, Indonesia, 55281
Contact: Riris A Ahmad, MD, PhD    +62 274 547 147    riris.andono@eliminatedengue.com   
Contact: Citra Indriani, MD, MPH    +62 274 547 147    citra.indriani@eliminatedengue.com   
Sponsors and Collaborators
Gadjah Mada University
Monash University
The Tahija Foundation
Investigators
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Principal Investigator: Adi Utarini, MD, PhD Faculty of Medicine, Universitas Gadjah Mada

Publications:
Dengue Vaccine Initiative. Dengue vaccine candidates in clinical development. (2016). Available at: http://www.denguevaccines.org/vaccine-development. (Accessed: 13th June 2016)
World Health Organization. Outcome of the Emergency Committee regarding clusters of microcephaly and Guillain-Barre syndrome. (2016)
World Health Organization. Mosquito (vector) control emergency response and preparedness for Zika virus. (2016). Available at: http://www.who.int/neglected_diseases/news/mosquito_vector_control_response/en/. (Accessed: 18th March 2016)
BPS - Statistics Indonesia. Badan Pusat Statistik. (2016). Available at: www.bps.go.id
Pilger, D., De Maesschalck, M., Horstick, O. & San Martín, J. L. Dengue outbreak response: documented effective interventions and evidence gaps. TropIKA 1, (2010)
Hayes, R. & Moulton, L. Cluster randomized trials. (Chapman & Hall/CRC, 2009)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Riris Andono Ahmad, Director of Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT03055585     History of Changes
Other Study ID Numbers: UGM_KE/FK/105/EC
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riris Andono Ahmad, Gadjah Mada University:
Wolbachia; Ae. aegypti; Indonesia; Dengue; Cluster-randomised trial
Additional relevant MeSH terms:
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Dengue
Chikungunya Fever
Zika Virus Infection
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Alphavirus Infections
Togaviridae Infections