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Clinical Trials/NCT03813069
NCT03813069CompletedPhase 2

A Within-subject Laboratory and Field Trial to Test the Use of Commercially Available Insect Repellents Against Contact From Musca Sorbens, the Putative Vector of Trachoma

London School of Hygiene and Tropical Medicine3 sites in 2 countries64 target enrollmentStarted: January 10, 2019Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
64
Locations
3
Primary Endpoint
Protective Efficacy (PE)

Study Overview

Brief Summary

Musca sorbens, a fly that feeds from ocular and nasal discharge on humans, is thought to be the vector of trachoma. We are developing methods of fly control that specifically target this species, in the hope of interrupting Ct transmission. To our knowledge, the use of commercially available insect repellents has never been tested for prevention of Musca sorbens fly-eye contact (i.e. nuisance and landing in the peri-ocular area). Given the likely necessity for prolonged and/or high frequency fly-eye contact for Ct transmission, the reduction of these contacts through the use of fly repellents presents an exciting opportunity for disease control. Here we propose a within-subject, non-masked, trial of the use of commercially available insect repellents against Musca sorbens, with two consecutive participant groups in the laboratory and in the field, and a primary endpoint of measuring the protective efficacy of each repellent product. Repellent products will be chosen from: DEET (N,N-diethyl-3-methylbenzamide), IR3535 (3-[N-butyl-N-acetyl]-aminopropionic acid ethyl ester), Picaridin (2-(2-hydroxyethyl)-1-piperidinecarboxylic acid 1-methylpropyl ester); PMD (para-Menthane-3,8-diol) or permethrin (m-Phenoxybenzyl)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate). Products tested will be either (1) topical repellents, or (2) in long-lasting, plastic formulations of repellents that can be worn on the body (wearable repellent technologies). The insect repellent synergist Vanillin (4-Hydroxy-3-methoxybenzaldehyde) may be added to the long-lasting plastic formulations, to improve the duration of protection.

Detailed Description

Introduction

Trachoma

Trachoma, a Neglected Tropical Disease (NTD), is the commonest infectious cause of blindness globally, affecting some of the world's poorest communities. Trachoma is caused by repeated ocular infection with the bacterium Chlamydia trachomatis (Ct). Active trachoma begins in childhood with recurrent episodes of follicular conjunctivitis (TF). Chronic inflammation results in immunologically mediated conjunctival scarring and in-turned eyelashes scratching the eye: trichiasis. Eventually sight is lost from irreversible corneal opacification.

Trachoma is currently endemic in 42 countries. The latest estimates from the Global Trachoma Mapping Programme (GTMP) suggest that 180 million people live in trachoma endemic areas and 3.2 million people have trachomatous trichiasis. Around 2.2 million people are visually impaired, of whom 1.2 million are blind. More than 80% of the burden of active trachoma is concentrated in 14 countries, mainly in the Sahel of West Africa and savannahs of East and Central Africa, where water supplies are often scarce.

Trachoma in Ethiopia

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
3 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Protective Efficacy (PE)

Time Frame: 2 months

The protection (protective efficacy, p) afforded by a repellent product will be presented as a percentage. p will be estimated by comparing fly-arm contact duration and fly-eye contact frequency, in laboratory and field trials respectively, after application (or wearing) of the repellent product to that during the control period.

Complete Protection Time (CPT)

Time Frame: 3 months

Median CPT will be estimated in stage two ('persistence') laboratory trials only, for those repellents that demonstrated more than 30 % PE. The complete protection time for a specific dose will be estimated as the time elapsed until the first fly landing on the arm in each replicate, and based on repeat estimates of CPT, the mCPT will be estimated using a Kaplan-Meier function.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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