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
|Condition or disease||Intervention/treatment|
|Loiasis Lymphatic Filariasis||Other: No intervention|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|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|
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)
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.
- 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
- 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
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
|Centre for Research on Filariasis and other Tropical Diseases (CRFilMT)|
|Principal Investigator:||Philip Budge, MD, PhD||Washington University School of Medicine|