Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06350851 |
| Other study ID # |
BA161WP1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
April 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Bioaster |
| Contact |
Karen LOUIS |
| Phone |
+33634452334 |
| Email |
karen.louis[@]bioaster.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Onchocerciasis, also known as river blindness, stands as the second leading cause of
infectious blindness worldwide. According to estimates by the World Health Organization
(WHO), approximately 25 million people are infected globally, with another 90 million at
risk. Over 99% of these cases occur in Africa, and vision loss affects around 1.15 million
individuals. The primary strategy for combating onchocerciasis currently is Community
Directed Treatment with Ivermectin (CDTI), requiring a minimum of 80% therapeutic coverage
for 10 -15 years.
Areas of West and Central Africa endemic for loiasis and mansonellasis, where ivermectin may
trigger severe side effects, pose a significant challenge in the battle against
onchocerciasis. Existing diagnostic tools for onchocerciasis have limitations that make
mapping, epidemiological assessments and verification of elimination of onchocerciasis
difficult. This situation underscores the importance of improving the specificity of
onchocerciasis diagnosis to reduce cross-reactivity and false results due to other parasitic
helminths in co-endemic regions. 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 to build up a bank of
well-characterized biological samples for the development and evaluation of a new rapid
diagnostic test for onchocerciasis. These studies will take place in the Centre, Littoral,
West and South regions of Cameroon over a one year period. 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. The study will begin with a screening phase during
which potential participants will be diagnosed for the different filariasis. Following this
screening phase, individuals meeting the inclusion criteria will be selected. Once consent
has been obtained, blood samples will be taken for test development and validation of the
onchocerciasis RDT. In fact, venous blood sample (in a tube containing EDTA) will be taken
for each participant, by venipuncture. After collection, the tube(s) containing the blood
will be stored in a cooler containing ice and transported to the laboratory within 6 hours of
collection. Once at the laboratory, the plasma will be immediately prepared, then aliquoted
and stored at -80ºC until transfer to BIOASTER for development and evaluation of the new
diagnostic test for onchocerciasis.
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.
