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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
| Centre for Research on Filariasis and other Tropical Diseases | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of cross-reactive antigenemia | To determine if the same antigens are present at each follow up | quarterly for 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Philip Budge, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Research on Filariasis and other Tropical Diseases (CRFilMT) | Yaoundé | Cameroon |
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.
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The data will be made available following publication. It will remain available indefinitely.
The data will be made publicly available.
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| ID | Term |
|---|---|
| D008118 | Loiasis |
| D004605 | Elephantiasis, Filarial |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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Plasma Buffy coat
| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |