Crimean-Congo Haemorrhagic FeverNCT06624787
Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care
A study testing Rapid Diagnostic Test in people with Crimean-Congo Haemorrhagic Fever, run by Liverpool School of Tropical Medicine at 6 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crimean-Congo Haemorrhagic Fever
- What is being tested?
- Rapid Diagnostic Test
- Type of treatment
- Medical device
- How many people
- 492 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- 4 May 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Atatürk University
Erzurum
Zulal Ozkurt, MD, zulalozkurt@atauni.edu.tr
- Recruiting
Erzurum City Hospital
Erzurum
Omer Karashin, MD, mrkrshn@hotmail.com
- Recruiting
Kastamonu Üniversitesi
Kastamonu
Hayrettin Akdeniz, MD, hakdeniz@kastamonu.edu.tr
- Recruiting
Ondokuz Mayis University (OMU) Faculty of Medicine, Department of Clinical Microbiology and Infectious Diseases, Samsun
Samsun
Ilkay Bozkurt, MD, drilkaybozkurt@gmail.com
- Recruiting
Sivas Cumhuriyet University
Sivas
Nazif Elaldi, MD, nelaldi61@yahoo.com
- Recruiting
Tokat Gaziosmanpaşa University
Tokat Province
Elif Ciftci, MD, elif-ciftci@hotmail.com
About this study
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.
- Conditions
- Crimean-Congo Haemorrhagic Fever
- Being tested
- Rapid Diagnostic Test
- Keywords
- CCHF, Medical Device, Lateral Flow, Rapid Diagnostic Test, LFT, RDT
- Medical subject headings
- Hemorrhagic Fever, Crimean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Diagnostic TestDevice
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 substantially cheaper than RT-PCR, and simpler to perform. A predicted price per test of around $5, whereas the current price of the RT-PCR test ranges from $1,000 to $1,200 for 96 reactions. The RDT does not require refrigeration or require specialist personnel to undertake, and the only additional apparatus needed is a stopwatch to monitor running time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
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.
Measured: 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 (4)
Usability of RDT via questionnaires answered by end users.
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
Measured: 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.
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.
Measured: 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.
To determine the Positive predictive value (PPV), Negative predictive value (NPV) and Accuracy of the RDT in all matrices.
Measured: 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 from blood drawn to diagnostic result - (from upload to the MoH server, and from the site knowing the RT-PCR result)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start4 May 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crimean-Congo Haemorrhagic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A diagnostic evaluation study where each participant undergoes both reference testing and the diagnostic testing
- Masking
- None (open label)
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, MEDEX, Mologic Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624787
- Sponsor's protocol ID
- LSTM 24-044
- Status last verified
- May 2026
- First submitted
- 14 Aug 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care
- ClinicalTrials.gov ID
- NCT06624787
- Acronym / sponsor ID
- LSTM 24-044
- Conditions
- Crimean-Congo Haemorrhagic Fever
- Keywords
- CCHF, Medical Device, Lateral Flow, Rapid Diagnostic Test, LFT, RDT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Medical Research Council, MEDEX, Mologic Ltd
- Study start
- 4 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- A diagnostic evaluation study where each participant undergoes both reference testing and the diagnostic testing
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Diagnostic TestThe 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 substantially cheaper than RT-PCR, and simpler to perform. A predicted price per test of around $5, whereas the current price of the RT-PCR test ranges from $1,000 to $1,200 for 96 reactions. The RDT does not require refrigeration or require specialist personnel to undertake, and the only additional apparatus needed is a stopwatch to monitor running time. | Device | – |
Primary outcome
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Diagnostic Test in people with Crimean-Congo Haemorrhagic Fever, run by Liverpool School of Tropical Medicine at 6 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ravi Lad (151 705 3364 ext. +44, ravi.lad@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.