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Spontaneous Antigenemia in Loiasis

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ClinicalTrials.gov Identifier: NCT04258670
Recruitment Status : Suspended (Study temporarily paused due to COVID-19 and expected to resume.)
First Posted : February 6, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Doris Duke Charitable Foundation
Centre for Research on Filariasis and other Tropical Diseases
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Loiasis Lymphatic Filariasis Other: No intervention

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Spontaneous Antigenemia in Loiasis, A Study of the Loiasis Antigens Responsible for Cross-reactivity in the Rapid Diagnostic Test for Lymphatic Filariasis
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : February 5, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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)

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.



Primary Outcome Measures :
  1. prevalence of specific cross-reactive L. loa antigens at baseline [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. Recurrence of cross-reactive antigenemia [ Time Frame: quarterly for 1 year ]
    To determine if the same antigens are present at each follow up


Biospecimen Retention:   Samples With DNA
Plasma Buffy coat


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted in the Okola health district (Lékié Division, Centre Region, Cameroon), situated about 40km northeast of Yaoundé, the political capital city of Cameroon. The Okola health district is highly endemic for loiasis. Participant will be recruited among those excluded from an Onchocerciasis study due to high Mf counts >20,000/mL.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258670


Locations
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Cameroon
Centre for Research on Filariasis and other Tropical Diseases (CRFilMT)
Yaoundé, Cameroon
Sponsors and Collaborators
Washington University School of Medicine
Doris Duke Charitable Foundation
Centre for Research on Filariasis and other Tropical Diseases
Investigators
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Principal Investigator: Philip Budge, MD, PhD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04258670    
Other Study ID Numbers: 201909003
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The deidentified IPD for all primary and secondary outcomes will be made publicly available either as a supplementary file in a research publication and/or made publicly available in a data repository maintained by the Becker Biomedical Library at Washington University.
Time Frame: The data will be made available following publication. It will remain available indefinitely.
Access Criteria: The data will be made publicly available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
diagnostics
cross-reactivity
Additional relevant MeSH terms:
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Filariasis
Elephantiasis, Filarial
Loiasis
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases