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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Ivermectin
DrugOral dose of ivermectin (150 micrograms/kg)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Behvioural response
Observed behavioural response(s) of adult female Musca sorbens when presented with faecal samples at baseline and each post-treatment time point.
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.
Sponsors and contacts
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