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Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

Phase 4
Completed
Conditions
Loiasis
Interventions
Registration Number
NCT05085665
Lead Sponsor
Washington University School of Medicine
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
Inclusion Criteria
  • Loa loa blood microfilariae of between 5,000 - 18,000 per mL
Exclusion Criteria
  • known allergy to ivermectin; severe comorbidities

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
IvermectinIvermectinAll eligible participants received a single dose (150 ug/kg) ivermectin by mouth
Primary Outcome Measures
NameTimeMethod
Cross-reactive Antigenemia7 days

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

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

🇨🇲

Yaoundé, Cameroon

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