Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioaster
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnant or breast-feeding women
Subjects having taken antihelminthic treatment less than 6 months before the inclusion date
Trial design
Design model
Parallel
Treatments tested in this trial
Biological samples collection (blood drawing + feces)
Biological/VaccineBlood and feces samples will be collected from each volunteer.
Treatment groups
400 Participants
are divided into 4 treatment groupsGroup A: Group1: Control subjects (non-infected with filariasis)Other 1 intervention
Group B: Group 2: Subjects mono-infected with Onchocerca volvulusOther 1 intervention
Group C: Group 3: Subjects mono-infected with Loa loaOther 1 intervention
Group D: Group 4: Subjects mono-infected with Mansonella perstans (alternatively co-infected with Loa loa)Other 1 intervention
Trial outcomes
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.
Time frame
Up to 52 weeks Source ClinicalTrials.gov