Spontaneous Antigenemia in Loiasis

NCT04258670 | Unknown

• 1 other identifier: 201909003
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Loiasis; Lymphatic Filariasis

Keywords

diagnostics; cross-reactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Recurrence of cross-reactive antigenemia

  quarterly for 1 year

Study Arms (2)

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

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.

Interventions

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)

Cross-reactive loiasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Doris Duke Charitable Foundation: collaborator
• Centre for Research on Filariasis and other Tropical Diseases: collaborator

Study Sites (1)

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

Yaoundé, Cameroon

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Buffy coat

MeSH Terms

Conditions

Loiasis; Elephantiasis, Filarial

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Philip Budge, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: January 23, 2020
• Primary Completion: May 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be made available following publication. It will remain available indefinitely.
• Access Criteria: The data will be made publicly available.

Locations

CA (1)