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Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 9, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Recruitment opened
    • Trial sites expanded: 0 → 6 locations
    • Start date changed from estimate of Apr 2026 to May 4, 2026
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Primary completion date: Sep 2025 to Sep 2026
    • Start date: Apr 2025 to Apr 2026
    • Study completion date: Sep 2026 to Sep 2027
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06624787
Lead Sponsor Liverpool School of Tropical Medicine
Collaborators: Medical Research Council, MEDEX, Mologic Ltd
Conditions
(from sponsor)		 Crimean-Congo Haemorrhagic Fever
Related terms Hemorrhagic Fever, Crimean
Enrollment 492 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov