NCT05085665

Brief Summary

This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 30, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 29, 2022

Completed
Last Updated

September 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

October 7, 2021

Results QC Date

August 30, 2022

Last Update Submit

August 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cross-reactive Antigenemia

    N of participants with detectable Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis (Filariasis Test Strip) on either day 1, 2, 3, or 7 post-treatment

    7 days

Study Arms (1)

Ivermectin

EXPERIMENTAL

All eligible participants received a single dose (150 ug/kg) ivermectin by mouth

Drug: Ivermectin

Interventions

single dose, 150 ug/kg

Ivermectin

Eligibility Criteria

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

You may qualify if:

  • Loa loa blood microfilariae of between 5,000 - 18,000 per mL

You may not qualify if:

  • known allergy to ivermectin; severe comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT)

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Loiasis

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

FilariasisSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr. Philip Budge
Organization
Washington University in St. Louis

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 20, 2021

Study Start

July 30, 2021

Primary Completion

August 31, 2021

Study Completion

September 30, 2021

Last Updated

September 29, 2022

Results First Posted

September 29, 2022

Record last verified: 2022-08

Locations