Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

NCT ID: NCT05085665

Last Updated: 2022-09-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2021-09-30

Brief Summary

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

Detailed Description

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A cohort of up to 50 participants with Loa loa microfilarial levels between 5,000 and 18,000 per ml/blood will be treated with ivermectin in an inpatient setting. Participants will be monitored for treatment-related adverse events for seven days post-treatment, and will have blood drawn on days 0, 1, 2, 3, and 7 post-treatment to assess for microfilarial load, cytokine, and antigen levels.

Conditions

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Loiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ivermectin

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

Group Type EXPERIMENTAL

Ivermectin

Intervention Type DRUG

single dose, 150 ug/kg

Interventions

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Ivermectin

single dose, 150 ug/kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* known allergy to ivermectin; severe comorbidities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Center for Research on Filariasis and Other Tropical Diseases, Cameroon

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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201909003(2)

Identifier Type: -

Identifier Source: org_study_id

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