- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, WC1E 7HT
- London School of Hygiene & Tropical Medicine
-
Contact:
- Robert T Jones, PhD
- Phone Number: +447745845880
- Email: robert.jones@lshtm.ac.uk
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Principal Investigator:
- Anna Last, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ivermectin treatment
Participants to receive safe oral dose of ivermectin
|
Oral dose of ivermectin (150 micrograms/kg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Musca sorbens larvae surviving to adulthood
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentration of ivermectin in faeces
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Eye Diseases
- Corneal Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Negative Bacterial Infections
- Conjunctivitis
- Conjunctival Diseases
- Eye Infections, Bacterial
- Eye Infections
- Chlamydiaceae Infections
- Conjunctivitis, Bacterial
- Chlamydia Infections
- Trachoma
- Organic Chemicals
- Macrolides
- Lactones
- Polyketides
- Ivermectin
Other Study ID Numbers
- 32885
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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