Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLondon School of Hygiene and Tropical Medicine

About this trial

Trachoma is caused by repeated Chlamydia trachomatis infection in the eye. Routes of infection include close person-to-person contact and contaminated clothing. In addition, the bazaar fly Musca sorbens has been implicated in transmission. These flies frequently visit the faces of children and have been found positive for C. trachomatis, which may be transferred from the body of the flies or their regurgitated or defecated material.

This study aims to give recruited healthy volunteers a safe dose of oral ivermectin. Their faeces will be collected over subsequent days to determine whether ivermectin excreted from the body results in faecal concentrations that are high enough to prevent emergence of M. sorbens developing in faeces. It will also quantify ivermectin concentrations in tears secretions and faecal samples for up to 30 days post-treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able and willing to give fully informed consent

Able to understand and comply with the study procedures

Able to produce a stool on most days

Consider themselves to be in good general health

Disqualifiers

Suspected or known to be sensitive or allergic to ivermectin

Women who are pregnant, nursing or intending to become pregnant

Aware of having any neurological disorders or recent history of seizures

History of travel to a region endemic for Loa loa.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ivermectin

    Drug

    Oral dose of ivermectin (150 micrograms/kg)

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Ivermectin treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Musca sorbens larvae surviving to adulthood

The difference in the mean number of Musca sorbens larvae surviving to adulthood in faecal samples collected at each post-treatment time point compared to pre-treatment samples. The treatment effect will be estimated separately at each time point.

Time frame
Days 1, 2, 3, 4, 5, 10 and 30 post treatment

Secondary outcomes

1

Concentration of ivermectin in faeces

The mean concentration of ivermectin in faecal samples (ng/g) and tear samples (ng/mL) at baseline and at each post-treatment time point.

Time frame
Days 1, 2, 3, 4, 5, 10 and 30 post treatment
2

First oviposition event

The time from presentation of each faecal sample to the first oviposition event by Musca sorbens at baseline and each post-treatment time point.

Time frame
Days 1, 2, 3, 4, 5, 10 and 30 post treatment
3

Behvioural response

Observed behavioural response(s) of adult female Musca sorbens when presented with faecal samples at baseline and each post-treatment time point.

Time frame
Days 1, 2, 3, 4, 5, 10 and 30 post treatment
4

Adult fly survival

The survival of adult female Musca sorbens when presented with faecal samples collected at baseline and each post-treatment time point, measured as time to death.

Time frame
Each time pointDays 1, 2, 3, 4, 5, 10 and 30 post treatment

Other outcomes

Sponsors and contacts

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