Impact of IIT-SIT on Dengue Clusters

ConditionDengue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNational Environment Agency, Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biological (Male Wolbachia-infected Aedes aegypti)

    Biological/Vaccine

    Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Intervention clustersExperimental treatment 1 intervention
Group B: Non-intervention clustersNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Impact of male Wolbachia-Aedes deployments on the time to cluster extinction

In this analysis, male Wolbachia-Aedes exposure will be considered as a binary classification based on whether the dengue cluster is allocated to the intervention or control arm. Cox proportional hazards models will be used to assess the intervention effect of male Wolbachia-Aedes by estimating the hazards ratio, which compares the probability of cluster extinction between arms from following up clusters from enrolment to cluster extinction.

Time frame
Up to 3 years
2

Impact of male Wolbachia-Aedes deployments on final cluster size, as measured by the difference in final cluster size between arms

In this analysis, male Wolbachia-Aedes exposure will be considered as a binary classification based on whether the dengue cluster is allocated to the intervention or control arm. Negative binomial models will be used to assess the intervention effect of male Wolbachia-Aedes by estimating the average treatment effect of the intervention on the final number of dengue cases in intervention versus control clusters.

Time frame
Up to 3 years

Secondary outcomes

1

Impact of male Wolbachia-Aedes deployments on the prevalence of Ae. aegypti/Ae. albopictus mosquitoes

The study will test whether male Wolbachia-Aedes deployments will effectively suppress Ae. aegypti mosquito populations as well as whether they have an off-target impact on Ae. albopictus mosquito populations in intervention vs. control clusters.

Time frame
Up to 3 years
2

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

In this analysis, male Wolbachia-Aedes exposure will be considered as a binary classification based on whether a patient's residence is in an dengue cluster receiving intervention or a control cluster, where residence is defined as the primary place where the patient resided at reporting date.

Time frame
Up to 3 years
3

Impact of male Wolbachia-Aedes deployments on the individual level reproduction number

In this analysis, the researchers will use notified and individually geolocated dengue cases to calculate the spatially adjusted time-varying reproduction number, which estimates the number of forward infections caused by an individual.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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National Environment Agency, Singapore

Lead sponsor

Ministry of Health, Singapore

Collaborator