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RecruitingNCT06894901

Impact of IIT-SIT on Dengue Clusters

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
900 (estimated)
Sponsor
National Environment Agency, Singapore · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBiological (Male Wolbachia-infected Aedes aegypti)Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Timeline

Start date
2025-03-20
Primary completion
2027-07-20
Completion
2028-01-20
First posted
2025-03-25
Last updated
2025-03-25

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT06894901. Inclusion in this directory is not an endorsement.