Impact of Project Wolbachia - Singapore on Dengue Incidence

National Environment Agency, Singapore

Status

Enrolling

Conditions

Dengue

Treatments

Biological: Biological (Male Wolbachia-infected Aedes aegypti)

Study type

Interventional

Funder types

Other

Identifiers

NCT05505682

IRB024

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.