Impact of IIT-SIT on Dengue Clusters

NCT ID: NCT06894901

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2028-01-20

Brief 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

Dengue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention clusters

Dengue clusters in residential estates that receive releases of male Wolbachia-infected Aedes aegypti

Group Type: EXPERIMENTAL

Biological (Male Wolbachia-infected Aedes aegypti)

Intervention Type: BIOLOGICAL

Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Non-intervention clusters

Dengue clusters in residential estates that do not receive releases of male Wolbachia-infected Aedes aegypti

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Biological (Male Wolbachia-infected Aedes aegypti)

Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Singapore

OTHER_GOV

Sponsor Role: collaborator

National Environment Agency, Singapore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lee Ching Ng

Group Director (Environmental Health Institute)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee Ching Ng Group Director (Environmental Health Institute), PhD

Role: PRINCIPAL_INVESTIGATOR

Environmental Health Institute

Locations

National Environment Agency

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Lee Ching Ng, PhD

Role: CONTACT

NG_Lee_Ching@nea.gov.sg

+65 67719108

Facility Contacts

Lee Ching Ng

Role: primary

NG_Lee_Ching@nea.gov.sg

Other Identifiers

IRB2025

Identifier Type: -

Identifier Source: org_study_id