Spontaneous Antigenemia in Loiasis

NCT ID: NCT04258670

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-23

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Loiasis Lymphatic Filariasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cross-reactive loiasis

This cohort will prospectively enroll 50 adults (age 18+) with cross-reactive antigenemia based on a positive filariasis test strip (FTS) and L. loa Mf counts \>20,000 Mf/mL.

No intervention

Intervention Type OTHER

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)

non-cross-reactive loiasis

This cohort will prospectively enroll 10 adults (age 18+) with a negative filariasis test strip (FTS) and L. loa Mf counts \>20,000 Mf/mL.

No interventions assigned to this group

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Doris Duke Charitable Foundation

OTHER

Sponsor Role collaborator

Centre for Research on Filariasis and other Tropical Diseases

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Budge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Centre for Research on Filariasis and other Tropical Diseases (CRFilMT)

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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201909003

Identifier Type: -

Identifier Source: org_study_id

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