- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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-
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London, Det Forenede Kongerige, WC1E 7HT
- London School of Hygiene & Tropical Medicine
-
Kontakt:
- Robert T Jones, PhD
- Telefonnummer: +447745845880
- E-mail: robert.jones@lshtm.ac.uk
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Ledende efterforsker:
- Anna Last, PhD
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Ivermectin treatment
Participants to receive safe oral dose of ivermectin
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Oral dose of ivermectin (150 micrograms/kg)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Musca sorbens larvae surviving to adulthood
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Concentration of ivermectin in faeces
Tidsramme: 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.
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Days 1, 2, 3, 4, 5, 10 and 30 post treatment
|
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First oviposition event
Tidsramme: Days 1, 2, 3, 4, 5, 10 and 30 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.
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Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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Behvioural response
Tidsramme: Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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Observed behavioural response(s) of adult female Musca sorbens when presented with faecal samples at baseline and each post-treatment time point.
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Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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Adult fly survival
Tidsramme: Each time pointDays 1, 2, 3, 4, 5, 10 and 30 post treatment
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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.
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Each time pointDays 1, 2, 3, 4, 5, 10 and 30 post treatment
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Infektioner
- Øjensygdomme
- Hornhindesygdomme
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Gram-negative bakterielle infektioner
- Konjunktivitis
- Konjunktivale sygdomme
- Øjeninfektioner, bakteriel
- Øjeninfektioner
- Chlamydiaceae infektioner
- Konjunktivitis, bakteriel
- Klamydia infektioner
- Trakom
- Organiske kemikalier
- Makrolider
- Lactoner
- Polyketider
- Ivermectin
Andre undersøgelses-id-numre
- 32885
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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