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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin treatment | Experimental | Participants to receive safe oral dose of ivermectin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | Oral dose of ivermectin (150 micrograms/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1, 2, 3, 4, 5, 10 and 30 post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1, 2, 3, 4, 5, 10 and 30 post treatment |
| First oviposition event |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London School of Hygiene & Tropical Medicine | London | WC1E 7HT | United Kingdom |
Study outcomes are not related to the participant.
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| ID | Term |
|---|---|
| D014141 | Trachoma |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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All participants to be given a single doe of ivermectin.
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Investigators exposing flies to the faeces of volunteers will be masked as to the treatment (whether the sample is pre- or post-treatment).
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The time from presentation of each faecal sample to the first oviposition event by Musca sorbens at baseline and each post-treatment time point.
| Days 1, 2, 3, 4, 5, 10 and 30 post treatment |
| Behvioural response | Observed behavioural response(s) of adult female Musca sorbens when presented with faecal samples at baseline and each post-treatment time point. | Days 1, 2, 3, 4, 5, 10 and 30 post treatment |
| 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. | Each time pointDays 1, 2, 3, 4, 5, 10 and 30 post treatment |
| D007239 | Infections |
| D002690 | Chlamydia Infections |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |