Applying Wolbachia to Eliminate Dengue (AWED) Trial
Tahapan Penelitian : Initial
Sponsor:
Universitas Gadjah Mada, Yogyakarta, Indonesia
Mitra Pelaksana:
Monash University, Melbourne, Australia; Yayasan Tahija Jakarta
No Registry
INA-A7OB6TW
Tanggal Input Registry : 01-08-2017
Tracking Information | |
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Tanggal Antisipasi Studi | 01-01-2018 |
Outcome Primer | Dengue incidence rate ratio in Wolbachia-treated versus untreated cluster. Symptomatic, virologically-confirmed dengue virus (DENV) infection of any severity |
Outcome Skunder | 1. Zika incidence rate ratio in Wolbachia-treated versus untreated cluster. Symptomatic, virologically-confirmed ZIKA virus (ZIKV) infection of any severity; 2. Chikungunya incidence rate ratio in Wolbachia-treated versus untreated cluster. Symptomatic, virologically-confirmed Chikungunya virus (CHIKV) infection of any severity |
Descriptive Information | |
Judul Penelitian Popular | Applying Wolbachia to Eliminate Dengue (AWED) Trial |
Judul Penelitian Ilmiah | A Non-blinded Cluster Randomized Controlled Trial to Assess the Efficacy of Wolbachia-Infected Mosquito Deployment to Reduce Dengue Incidence in Yogyakarta, Indonesia |
Jenis Penelitian | Interventional |
Intervensi | Intervention arm: Deployment of Wolbachia-infected Aedes aegypty mosquitoes, in addition to standard practice dengue control activities Comparison arm: No intervention, Standard practice dengue control activities |
Jumlah Subyek Penelitian | 10000 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: Participants must meet the following inclusion criteria: 1. Fever (either self reported or objectively measured, e.g (thypmanic membrane temperatur >=38 C, with a date of onset between 1-4 prior to the day of presentation; 2. Aged between 3-30 years old; 3. Resided in the study area every night for the 10 days preceding illness onsetExclusion Criteria: Participants will not be eligible for inclusion if any of the following are identified: 1. Localising features suggestive of an alternative diagnosis eg severe diarrhea, otitis, pneumonia 2. Prior enrolment in the study within the previous 4 weeks |
Administrative Information | |
Nomor Persetujuan Etik | KE/FK/159/EC/2016 |
Nomor Persetujuan Material Transfer Agreement | |
Nomor Persetujuan Pelaksanaan Uji Klinik | |
Other Study ID Numbers | NCT03055585 |
Contact Person | dr. Citra Indriani, MPH; +62811282879 |