- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07657143
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma (IVERMUSC)
Evaluation of the Impact of Oral Ivermectin (150 Micrograms/kg) on Musca Sorbens, the Putative Vector of Trachoma
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
-
London, Storbritannien, WC1E 7HT
- London School of Hygiene & Tropical Medicine
-
Kontakt:
- Robert T Jones, PhD
- Telefonnummer: +447745845880
- E-post: robert.jones@lshtm.ac.uk
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Huvudutredare:
- Anna Last, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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
- Aged 18 to 65 years
Exclusion Criteria:
- 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.
- Currently taking acenocoumarol, warfarin or levimasole
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Ivermectin treatment
Participants to receive safe oral dose of ivermectin
|
Oral dose of ivermectin (150 micrograms/kg)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Musca sorbens larvae surviving to adulthood
Tidsram: Days 1, 2, 3, 4, 5, 10 and 30 post treatment
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Concentration of ivermectin in faeces
Tidsram: Days 1, 2, 3, 4, 5, 10 and 30 post treatment
|
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
Tidsram: Days 1, 2, 3, 4, 5, 10 and 30 post treatment
|
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
Tidsram: Days 1, 2, 3, 4, 5, 10 and 30 post treatment
|
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
Tidsram: Each time pointDays 1, 2, 3, 4, 5, 10 and 30 post treatment
|
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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Infektioner
- Ögonsjukdomar
- Kornea sjukdomar
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Gram-negativa bakteriella infektioner
- Konjunktivit
- Konjunktiva sjukdomar
- Ögoninfektioner, bakteriell
- Ögoninfektioner
- Chlamydiaceae-infektioner
- Konjunktivit, bakteriell
- Klamydiainfektioner
- Trakom
- Organiska kemikalier
- Makrolider
- Laktoner
- Polyketider
- Ivermektin
Andra studie-ID-nummer
- 32885
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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