The study of Project Wolbachia impact on dengue incidence
National Environment Agency, Singapore is recruiting patients for the clinical trial of Impact of Project Wolbachia - Singapore on Dengue Incidence.
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.
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.
The researchers plan that July 28, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in January 2025.
Among primary outcome measures are the Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters and Dengue cases data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.
The study will take place at the National Environment Agency, Singapore, Singapore.
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 can be enrolled into this research.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05505682.
