Clinical trial NCT06624787: Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care
Official title: Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crimean-Congo Haemorrhagic Fever
Keywords: CCHF
Medical Device
Lateral Flow
Rapid Diagnostic Test
LFT
RDT
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: MEDEX
name: Mologic Ltd
First posted: 2024-10-03
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A diagnostic evaluation study where each participant undergoes both reference testing and the diagnostic testing
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

Participants aged 18 years or older Suspected CCHF infection that requires a RT-PCR diagnosis and venous blood draw Willingness to comply with study procedures and consent to the study Presents at 1 of 4 listed sites

Exclusion Criteria:

* In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: From the date/time of blood draw of the first participant until all diagnostic results have been received (up to two weeks from blood draw)
Secondary outcomes:
measure: Usability of RDT via questionnaires answered by end users.
timeFrame: Once all questionnaires have been completed, and quality checked - this should occur upto a month after the last recruit
measure: To determine the most suitable matrices that have the minimum TPP as required by the WHO for RDTs for CCHF detection.
timeFrame: From the date/time of blood draw of the first participant until all diagnostic results and questionnaires have been received - this should be completed upto a month after the last recruit
measure: Using the PPV, NPV and accuracy of the RDT in all matrices.
timeFrame: From the date/time of blood draw of the first participant until all diagnostic results have been received (up to two weeks from first blood draw of database lock)
measure: To determine the time taken for a CCHF result from blood draw.
timeFrame: From the date/time of blood draw of the first participant until all diagnostic results have been received (this should occur unto a month after the last recruit)
Other outcomes:
measure: Exploratory Outcome 1 - To identify the types of clinical presentations in terms of SGS scores, symptomatic phases, and outcomes of CCHF in endemic areas of Turkey.
timeFrame: From the date/time of blood draw of the first participant until all diagnostic results and clinical information has been received - this should occur unto a month after the last recruit
measure: Exploratory Outcome 2 - Sensitivity of the RDT among local strains. Indirectly, information on the CCHFV strains circulating in Turkey during 2025 CCHF season will be collected.
timeFrame: From the date/time of blood draw of the first participant until all diagnostic results, clinical information and sequencing results have been received - this should occur upto 6 months after the last recruit
Locations:
Study officials:
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