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Recruiting NCT06894901

Impact of IIT-SIT on Dengue Clusters

No phase Interventional Dengue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biological (Male Wolbachia-infected Aedes aegypti).
Who it may be relevant to
Registry conditions: Dengue. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessing the Efficacy of Incompatible Insect Technique Coupled with Sterile Insect Technique (IIT-SIT) to Manage Large Dengue Clusters: a Randomized Controlled Trial

Overview

This randomized controlled trial aims to evaluate the efficacy of Wolbachia-infected male mosquitoes combined with sterile insect technique (IIT-SIT) to mitigate active dengue transmission in Singapore.

Detailed description

Aedes-borne diseases are expected to increase in geographical coverage and intensity due to climate change and rapid urbanization. It has been demonstrated that Wolbachia-mediated incompatible insect technique coupled with sterile insect technique (IIT-SIT) is highly effective in suppressing Aedes populations and subsequently reducing dengue risk. However, the efficacy of the tool in mitigating ongoing transmission is unknown.

The researchers outline a randomized controlled trial to be conducted in high-rise public housing estates in Singapore to assess the efficacy of IIT-SIT to mitigate active dengue transmission. Specifically, the study will determine whether the release of male Wolbachia-infected Aedes aegypti mosquitoes can curtail the growth of dengue clusters, defined operationally by the Singapore National Environment Agency (NEA) as two or more reported dengue cases within a 150-meter radius and with illness onset dates within 14 days of each other. This study will randomize eligible clusters into intervention/control arms in real-time. Clusters assigned to the intervention arm will receive IIT-SIT treatment until cluster extinction (i.e. when no further cases are linked to the cluster). This trial closely mimics how IIT-SIT could be used as an additional tool for outbreak management, by treating areas with active dengue transmission in real-time. Conventional vector control measures will be carried out as per NEA's usual outbreak management practices in both intervention and control clusters. The intervention efficacy will be estimated through two primary endpoints: (1) probability of cluster extinction, as estimated from the time-to-cluster extinction among intervention versus control clusters; and (2) final size of the dengue cluster, as estimated by the difference in the final number of dengue cases in intervention versus control clusters.

This study will provide evidence from a randomized controlled trial for the efficacy of IIT-SIT in curbing ongoing transmission and provide an epidemiological basis for integrating IIT-SIT into the existing arsenal of outbreak management tools. The trial will assess the technology's feasibility for operationalization, and identify difficulties in implementation prior to larger-scale use for outbreak control.

Interventions

  • Biological Biological (Male Wolbachia-infected Aedes aegypti)
    Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Primary outcome measures

  • Impact of male Wolbachia-Aedes deployments on the time to cluster extinction [Time frame: Up to 3 years]
  • Impact of male Wolbachia-Aedes deployments on final cluster size, as measured by the difference in final cluster size between arms [Time frame: Up to 3 years]
Secondary outcome measures (3)
  • Impact of male Wolbachia-Aedes deployments on the prevalence of Ae. aegypti/Ae. albopictus mosquitoes [Time frame: Up to 3 years]
  • Impact of male Wolbachia-Aedes deployments on dengue risk in clusters, measured by odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls [Time frame: Up to 3 years]
  • Impact of male Wolbachia-Aedes deployments on the individual level reproduction number [Time frame: Up to 3 years]

Eligibility criteria

Eligible dengue clusters will be limited to public housing estates and with at least 10 dengue cases comprising that dengue cluster before allocation into intervention or control arms. The selected clusters will be in areas with relatively high sector-level GAI of at least 0.2 at the time of the 10th reported case. Additionally, the first 10 cases must be reported within 30 days of the first case. Additionally, clusters must be in areas which have never experienced Wolbachia-Aedes releases and at least 700 m away from existing Wolbachia-Aedes release areas.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Singapore · 1 center
  • National Environment Agency — Singapore

Identifiers

NCT: NCT06894901 · IRB2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗