Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination

NCT06350851 | Recruiting

• 1 other identifier: BA161WP1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission. To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected. At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.

Conditions

Onchocerciasis; Loiasis; Mansonelliasis; Healthy Volunteers

Keywords

Onchocerca volvulus; Loa loa; Mansonella perstans; Biplex Rapid Diagnostic Test; Neglected Tropical Diseases

Outcome Measures

Primary Outcomes (1)

• Evaluation of the performance of the prototype diagnostic test

  The prototype will be evaluated with all plasma samples in order to determine the dynamic range of the test and the associated variability, as well as its performance in terms of sensitivity and specificity in relation to non-infected samples, and the absence of cross-reactivity with samples infected by Loa loa and Mansonella perstans.

  Up to 52 weeks

Study Arms (4)

Group1: Control subjects (non-infected with filariasis)

OTHER

Blood drawing + feces sample collection

Biological: Biological samples collection (blood drawing + feces)

Group 2: Subjects mono-infected with Onchocerca volvulus

OTHER

Blood drawing + feces sample collection

Biological: Biological samples collection (blood drawing + feces)

Group 3: Subjects mono-infected with Loa loa

OTHER

Blood drawing + feces sample collection

Biological: Biological samples collection (blood drawing + feces)

Group 4: Subjects mono-infected with Mansonella perstans (alternatively co-infected with Loa loa)

OTHER

Blood drawing + feces sample collection

Biological: Biological samples collection (blood drawing + feces)

Interventions

Biological samples collection (blood drawing + feces) BIOLOGICAL

Blood and feces samples will be collected from each volunteer.

Group 2: Subjects mono-infected with Onchocerca volvulus; Group 3: Subjects mono-infected with Loa loa; Group 4: Subjects mono-infected with Mansonella perstans (alternatively co-infected with Loa loa); Group1: Control subjects (non-infected with filariasis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects informed of the objectives of the study and who signed a consent form
• Subjects without filariasis (for control subjects), or
• Subjects mono-infected with Onchocerca volvulus, or
• Subjects mono-infected with Loa loa, or
• Subjects mono-infected with Mansonella perstans or alternatively co-infected with Mansonella perstans and Loa loa

You may not qualify if:

• Pregnant or breast-feeding women

Sponsors & Collaborators

• Bioaster: lead

Study Sites (1)

Higher Institute for Scientific and Medical Research

Yaoundé, 5797, Cameroon

RECRUITING

Related Links

• Higher Institute for Scientific and Medical research website
• BIOASTER website

MeSH Terms

Conditions

Onchocerciasis; Loiasis; Mansonelliasis; Dipetalonema Infections; Neglected Diseases

Interventions

Blood Specimen Collection; Defecation

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Philippe LEISSNER

  Bioaster

  STUDY DIRECTOR

• Joseph KAMGNO

  ISM (Higher Institute for Scientific and Medical Research)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie KOENIG

CONTACT

+33634452334; marie.koenig@bioaster.org

Marion DARNAUD

CONTACT

+33481111002; marion.darnaud@bioaster.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 5, 2024
• Study Start: April 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)