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Recruiting NCT06624787

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

No phase Interventional Crimean-Congo Haemorrhagic Fever

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rapid Diagnostic Test.
Who it may be relevant to
Registry conditions: Crimean-Congo Haemorrhagic Fever. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device 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

Primary outcome measures

  • Sensitivity and Specificity [Time frame: 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 outcome measures (4)
  • Usability of RDT via questionnaires answered by end users. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Turkey (Türkiye) · 6 centers
  • 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

Identifiers

NCT: NCT06624787 · LSTM 24-044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗