Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624787
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Development of a Rapid Diagnostic Test to Identify Crimean-Congo Haemorrhagic Fever At the Point-Of-Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Rapid Diagnostic Test to Identify Crimean-Congo Haemorrhagic Fever At the Point-Of-Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this medical device diagnostic evaluation study is to determine if this novel lateral flow device can detect Crimean-Congo Hemorrhagic Fever CCHF at the point of care in secondary health care clinics in Turkey The main outcome is to determine the sensitivity and specificity of the tests for CCHF in samples of whole blood serum and capillary blood compared to a gold-standard of PCR for participants that present at 4 endemic sites secondary health care clinics in Turkey in 492 adults who are suspected to have been infected with CCHF The study aims to hopes to achieve at least the minimum required sensitivity of 90 and specificity of 80 as required by the WHO
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None