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Completed

NCT Number: NCT05505682

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Environment Agency

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological (Male Wolbachia-infected Aedes aegypti)

Biological

Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Prevalence of Ae. aegypti/Ae. albopictus mosquitoes

    Time frame: Up to 3 years

    Data will be obtained from the national gravitrap surveillance system

  2. Public Attitudes, Perceptions & Knowledge (APK) of Wolbachia and other vector control interventions

    Time frame: Up to 3 years

    Sentiment surveys pre-trial and during the course of the trial, using true/false and Likert-type scales. Higher scores mean better outcomes.

Sponsors and collaborators

Lead sponsor

National Environment Agency, Singapore

Other Gov

Collaborators

  • Ministry of Health, Singapore

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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