Impact of Project Wolbachia - Singapore on Dengue Incidence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

724428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-28

Study Completion Date

2024-09-13

Brief Summary

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The study is a cluster-randomised controlled trial set in Singapore, to assess if the deployment of male Wolbachia-infected Aedes aegypti mosquitoes can reduce dengue incidence in intervention clusters.

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Detailed Description

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The study is designed as a parallel, two-arm, non-blinded cluster-randomised controlled trial to be conducted in high-rise public housing estates in Singapore. The aim is to determine whether large-scale deployment of male Wolbachia-infected Ae. aegypti mosquitoes can significantly reduce dengue incidence in intervention clusters. The investigators will use the cluster-randomised design, with the study area comprising 15 clusters with a total area of 10.9 km2, covering approximately 722,000 residents in 1,700 apartment blocks. Eight clusters will be randomly selected to receive the intervention, while the other seven will serve as non-intervention clusters. Intervention efficacy will be estimated through two primary endpoints: (1) odds ratio of Wolbachia exposure distribution (i.e. probability of living in an intervention cluster) among laboratory-confirmed reported dengue cases compared to test-negative controls, and (2) laboratory-confirmed reported dengue counts normalized by population size in intervention versus non-intervention clusters.

Conditions

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Dengue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel, two-arm, non-blinded cluster-randomised controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention clusters

Residential areas that receive releases of male Wolbachia-infected Aedes aegypti

Group Type EXPERIMENTAL

Biological (Male Wolbachia-infected Aedes aegypti)

Intervention Type BIOLOGICAL

Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Non-intervention clusters

Residential areas that do not receive releases of male Wolbachia-infected Aedes aegypti

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Biological (Male Wolbachia-infected Aedes aegypti)

Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Dengue-suspected patients living in the intervention and non-intervention clusters whose blood samples are collected by a national network of diagnostic laboratories that support private clinics, public polyclinics, or public/private hospitals.
* Test positive cases: Patients with virologically confirmed DENV infection through RT-qPCR, testing positive for NS1 antigen or IgM. A positive test for any of the three assays would classify the patient as a dengue case.
* Test negative controls: Patients with negative test results for DENV through RT-qPCR, NS1 antigen ELISA, or DENV IgM.

Eligible Sex

ALL

Accepts Healthy Volunteers

No