Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

The Washington University

Status and phase: Completed; Phase 4

Conditions: Loiasis

Treatments: Drug: Ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT05085665

201909003(2)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• known allergy to ivermectin; severe comorbidities

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Ivermectin

Experimental group

Description:

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

Treatment:

Drug: Ivermectin