Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT05085665
Collaborator
Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT) (Other)
39
1
2
19.1
Study Details
Study Description
Brief Summary
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Actual Study Start Date
:
Jul 30, 2021
Actual Primary Completion Date
:
Aug 31, 2021
Actual Study Completion Date
:
Sep 30, 2021
Outcome Measures
Primary Outcome Measures
- cross-reactive antigenemia [7 days]
detection of Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Loa loa blood microfilariae of between 5,000 - 18,000 per mL
Exclusion Criteria:
- known allergy to ivermectin; severe comorbidities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT) | Yaoundé | Cameroon |
Sponsors and Collaborators
- Washington University School of Medicine
- Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05085665
Other Study ID Numbers:
- 201909003(2)
First Posted:
Oct 20, 2021
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms: