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Clinical Trials/NCT05505682
NCT05505682CompletedNot Applicable

Assessing the Efficacy of Male Wolbachia-infected Mosquito Deployments to Reduce Dengue Incidence in Singapore: a Cluster Randomized Controlled Trial

National Environment Agency, Singapore1 site in 1 country724,428 target enrollmentStarted: July 28, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
724,428
Locations
1
Primary Endpoint
Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Intervention clusters

Experimental

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

Intervention: Biological (Male Wolbachia-infected Aedes aegypti) (Biological)

Outcomes

Primary Outcomes

Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters

Time Frame: Up to 3 years

Dengue cases data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.

Odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls

Time Frame: Up to 3 years

Dengue cases and dengue test-negative controls data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.

Secondary Outcomes

  • Prevalence of Ae. aegypti/Ae. albopictus mosquitoes(Up to 3 years)
  • Public Attitudes, Perceptions & Knowledge (APK) of Wolbachia and other vector control interventions(Up to 3 years)

Investigators

Sponsor
National Environment Agency, Singapore
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Lee Ching Ng

Group Director (Environmental Health Institute)

National Environment Agency, Singapore

Study Sites (1)

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