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Completed

NCT Number: NCT05085665

Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

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

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Key information

Conditions

Loiasis Filariasis Helminthiasis Infections Nematode Infections Parasitic Diseases Secernentea Infections Spirurida Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • known allergy to ivermectin; severe comorbidities

Treatment and study plan

Ivermectin

Drug

single dose, 150 ug/kg

Primary outcomes

  1. Cross-reactive Antigenemia

    Time frame: 7 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Center for Research on Filariasis and Other Tropical Diseases, Cameroon

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2021
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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