NCT05452447: AEGIS ABV

Spatial Repellents for Aedes-borne Virus Control in Sri Lanka

Completed NA Last updated 15 September 2025

What this trial tests

NA trial testing Transfluthrin in Arbovirus Infections in 6,949 participants. Completed in 30 June 2025.

Timeline

2 March 2023

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	University of Notre Dame
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	6,949
Start date	2 March 2023
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	2 locations across Sri Lanka

Drugs / interventions tested

• Transfluthrin
• Placebo

Conditions studied

• Arbovirus Infections — all drugs for Arbovirus Infections →

Sponsor

University of Notre Dame

Who can join

6 Months and older, any sex, with Arbovirus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of a single SR product, in reducing DENV infection and active Aedes-borne virus (ABV) disease in human cohorts. The study design will be a prospective, cluster randomized controlled trial (cRCT). Although not a specific objective of this project, an overall goal is to allow for official recommendations (or not) from the World Health Organization (WHO) for the use of SRs in public health. A WHO global policy recommendation will establish evaluation systems of SR products to regulate efficacy evaluations, thereby increasing quality, overall use and a consequent reduction in disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A cluster-randomized, placebo-controlled trial to evaluate the efficacy of a spatial repellent (Mosquito Shield™) against Aedes-borne virus infection among children ≥ 4-16 years of age in the Gampaha District, Sri Lanka: study protocol (the AEGIS program).
   Tissera H, Dheerasinghe DSAF, Malavige N, de Silva HA, et al · · 2023 · cited 8× · PMID 36600308 · DOI 10.1186/s13063-022-06998-z
2. A cluster randomized, placebo control trial to evaluate the efficacy of a spatial repellent (Mosquito ShieldTM) against Aedes-borne virus infection among children ≥ 4–16 years of age in the Gampaha District, Sri Lanka: study protocol (the AEGIS program)
   Tissera H, Dheerasinghe DAF, Malavige N, de Silva HA, et al · · 2022 · DOI 10.21203/rs.3.rs-2179301/v1