NCT07657143

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
4mo left

Started Jul 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

June 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 11, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

TrachomaIvermectinMusca flies

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Concentration of ivermectin in faeces

    Days 1, 2, 3, 4, 5, 10 and 30 post treatment

  • First oviposition event

    Days 1, 2, 3, 4, 5, 10 and 30 post treatment

  • Behvioural response

    Days 1, 2, 3, 4, 5, 10 and 30 post treatment

  • Adult fly survival

    Each time pointDays 1, 2, 3, 4, 5, 10 and 30 post treatment

Study Arms (1)

Ivermectin treatment

EXPERIMENTAL

Participants to receive safe oral dose of ivermectin

Drug: Ivermectin

Interventions

Oral dose of ivermectin (150 micrograms/kg)

Ivermectin treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London School of Hygiene & Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Trachoma

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Conjunctivitis, BacterialEye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsChlamydia InfectionsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesCorneal Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Masking Details
Investigators exposing flies to the faeces of volunteers will be masked as to the treatment (whether the sample is pre- or post-treatment).
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants to be given a single doe of ivermectin.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 18, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Study outcomes are not related to the participant.

Locations