Spontaneous Antigenemia in Loiasis

Lymphatic Filariasis Clinical Trial

Official title:

Spontaneous Antigenemia in Loiasis, A Study of the Loiasis Antigens Responsible for Cross-reactivity in the Rapid Diagnostic Test for Lymphatic Filariasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04258670
• Other study ID #: 201909003
• Status: Active, not recruiting
• Start date: January 23, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This prospective study will enroll and follow 60 loiasis patients with high worm burden to monitor the spontaneous release of filarial antigen in peripheral blood. This study will define the cross-reactive antigen profile of persons with spontaneous loiasis antigenemia, and determine whether it varies with time.

Description:

Global efforts to eradicate lymphatic filariasis (LF) depend on rapid diagnostic tests (RDTs) that detect Wuchereria bancrofti circulating filarial antigen but these tests are unreliable in African nations where Loa loa is co-endemic because they yield false-positive results in some individuals with loiasis. The goals of this project are to define the cross-reactive antigen profile of persons with spontaneous antigenemia, how it varies over time, and to determine which L. loa antigens in cross-reactive sera best distinguish loiasis cross-reactivity from LF.

This prospective study will prospectively enroll 50 adults who presented with cross-reactive antigenemia at screening and 10 negative controls. Participants will followed for one year and tested every three months for persistence of antigenemia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to give informed consent

• Loiasis Mf count > 20,000 Mf/mL

• Resident of study area

• No evidence of severe or systemic comorbidities

• Consent to storage of blood samples for future study

Exclusion Criteria:

• Subject plans to move from the study area during subsequent 12 months

Related Conditions & MeSH terms

• Filariasis
• Loiasis
• Lymphatic Filariasis

Intervention

Other:
• No intervention
Patients in these cohorts will not be given anti-filariasis therapies because these drugs are not approved for use in patients with high worm burdens (>20,000 Mf/mL)

Locations

Country	Name	City	State
Cameroon	Centre for Research on Filariasis and other Tropical Diseases (CRFilMT)	Yaoundé

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Centre for Research on Filariasis and other Tropical Diseases, Doris Duke Charitable Foundation

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of specific cross-reactive L. loa antigens at baseline	Prevalence of filariasis test strip (FTS) positive individuals at screening. Cross-reactive proteins in plasma will be identified by mass-spectrometry to identify a cross-reactive biomarker	1 day
Secondary	Recurrence of cross-reactive antigenemia	To determine if the same antigens are present at each follow up	quarterly for 1 year