Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

Loiasis Clinical Trial

Official title:

Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05085665
• Other study ID #: 201909003(2)
• Status: Completed
• Phase: Phase 4
• Start date: July 30, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• known allergy to ivermectin; severe comorbidities

Related Conditions & MeSH terms

• Loiasis

Intervention

Drug:
• Ivermectin
single dose, 150 ug/kg

Locations

Country	Name	City	State
Cameroon	Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT)	Yaoundé

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Center for Research on Filariasis and Other Tropical Diseases, Cameroon

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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