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

February 17, 2026 updated by: Liverpool School of Tropical Medicine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

492

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
To determine the sensitivity and specificity of RDT 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.
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

Outcome Measure
Measure Description
Time Frame
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 ease of use of the RDT at the point of care in CCHF-endemic settings by end users answering a questionnaire designed with a 5-point Likert scale
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 sensitivity, specificity, ease-of-use questionnaires, Positive predictive value, Negative predictive value and accuracy of RDT in all matrices to determine the most suitable matrix(ices) at the end-user setting.
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 Positive predictive value (PPV), Negative predictive value (NPV) and Accuracy of the RDT in all matrices.
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)
Time from blood drawn to diagnostic result - (from upload to the MoH server, and from the site knowing the RT-PCR result)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
Sensitivity of the RDT among clinical, demographic, outcome subgroups of suspected CCHF-infected individuals in Turkey. Indirectly information of the clinical characteristics and demographics of the patients that require a CCHF diagnosis during 2025 CCHF in the selected clinics will be collected.
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
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.
Time Frame: 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
Sequencing data on negative RDT results and PCR positive results to determine whether CCHFV strain has a negative impact on test sensitivity
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool School of Tropical Medicine

Collaborators

Medical Research Council
MEDEX
Mologic Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSTM 24-044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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