Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-22
Brief Title:
Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination
Sponsor:
Bioaster
Organization:
Bioaster
Study Overview
Official Title:
Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Obi1
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
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
Detailed 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 115 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 tubes 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
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 tubes 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None