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

Обзор

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.

Вмешательства

• Устройство Rapid Diagnostic Test
  The Liverpool School of Tropical Medicine (LSTM) in collaboration with Global Access Diagnostics (GADx) have achieved the development of the first RDT to detect CCHF viral antigens with a sensitivity and specificity that exceeds the minimum recommendation in the WHO target product profile (TPP)of \>80% and \>90% for sensitivity and specificity respectively for minimal performance in pre-clinical studies. The RDT is not only faster providing a test result within 20 minutes, but is also substantia

Первичные конечные точки

• Sensitivity and Specificity [Срок оценки: 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)]

Вторичные конечные точки (4)

• Usability of RDT via questionnaires answered by end users. [Срок оценки: Once all questionnaires have been completed, and quality checked - this should occur upto a month after the last recruit]
• To determine the most suitable matrices that have the minimum TPP as required by the WHO for RDTs for CCHF detection. [Срок оценки: 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]
• Using the PPV, NPV and accuracy of the RDT in all matrices. [Срок оценки: 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)]
• To determine the time taken for a CCHF result from blood draw. [Срок оценки: 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)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Turkey (Türkiye) · 6 центров

• Atatürk University — Erzurum
• Erzurum City Hospital — Erzurum
• Kastamonu Üniversitesi — Kastamonu
• Ondokuz Mayis University (OMU) Faculty of Medicine, Department of Clinical Microbiology an — Samsun
• Sivas Cumhuriyet University — Sivas
• Tokat Gaziosmanpaşa University — Tokat Province

Идентификаторы

NCT: NCT06624787 · LSTM 24-044

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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