Syphilis InfectionNCT06584214
Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.
A study testing Diagnostic test: Determine™ Syphilis Advanced test in people with Syphilis Infection, run by Abbott Rapid Dx at 1 site in Uganda.
Trial summary
This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syphilis Infection
- What is being tested?
- Diagnostic test: Determine™ Syphilis Advanced test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older.
- The participant has confirmed previous / current syphilis according to their medical history, or the participant has unknown or negative syphilis infection status.
- The participant agrees to provide written informed consent.
- The participant agrees to complete all aspects of the study.
- Additional inclusion criteria for frozen samples:
- The ethics committee-required written informed consent for study testing, or required documentation for sample use from a commercial vendor, is available.
- Sufficient volume for testing is available and the sample quality is adequate (for example no significant sample hemolysis)
- The sample must have been collected in EDTA vacutainers or serum tubes, processed to plasma and the plasma frozen within 36 hours of blood collection.
Who cannot join
- Participant has already participated in this study on a previous occasion.
- Participant is deemed vulnerable and / or unfit for participation in the study by the Investigator.
- Participant is unwilling or unable to provide informed consent.
- Participant is currently enrolled in a study to evaluate an investigational new drug or vaccine.
- Additional exclusion criteria for frozen samples
- The sample has undergone more than one freeze thaw cycle
- The sample has been kept at -20 °C (± 5 °C) longer than 12 months. If the sample has been kept longer than 12 months, the storage temperature must have been colder than -20 °C (± 5 °C).
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Uganda Virus Research Institute
Entebbe
Pontiano Kaleebu, Professor, MD PhD, Pontiano.Kaleebu@mrcuganda.org
About this study
Official title: A Prospective, Multi-centre Study to Evaluate the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.
This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization\'s TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.
Read the detailed description
Syphilis is a sexually transmitted infection (STI) caused by the spirochete Treponema pallidum subspecies. Globally, there were an estimated 7.1 million adults between 15 and 49 years of age who acquired syphilis in 2020. Syphilis is transmitted through sexual contact with infectious lesions, through blood transfusions and from mother-to-child during pregnancy; most infections are asymptomatic or unrecognized. Without treatment, the disease lasts for many years and is divided into stages: primary syphilis, secondary syphilis and latent syphilis. Mother-to-child transmission of syphilis (congenital syphilis) can adversely affect the foetus, but this can be averted by early detection and treatment of the mother during pregnancy.
Determine™ Syphilis Advanced is an in vitro, visually read, qualitative immunoassay for the detection of antibodies to Treponema pallidum, in human capillary and venous whole blood, plasma or serum.
The test is intended for professional use, and the performance evaluation will be performed by professional healthcare and laboratory staff. Results for all sample types (capillary and venous whole blood, plasma or serum) will be evaluated against reference test results. In addition, for a sub-cohort, the Determine™ Syphilis Advanced test will be compared with the commercially available Determine™ Syphilis TP and the SERODIA-TPPA tests. Study staff performing the testing using the Determine™ Syphilis Advanced will be blinded to the participants' syphilis infection status and all other study syphilis test results. The study will enrol prospective participants, and will also have a retrospective study group.
- Conditions
- Syphilis Infection
- Being tested
- Diagnostic test: Determine™ Syphilis Advanced test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test: Determine™ Syphilis Advanced testDiagnostic test
The Determine™ Syphilis Advanced test is intended as an aid in detecting antibodies to Treponema pallidum in individuals with current or past infection.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic test: Determine™ Syphilis Advanced test | Experimental | Diagnostic test: Testing using the Determine™ Syphilis Advanced test will be conducted by study staff members. Receives: Diagnostic Test: Diagnostic test: Determine™ Syphilis Advanced test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test results using fingerstick capillary whole blood, venous whole blood, serum and venous plasma, when the test is performed by professional users.
The diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test will be evaluated versus laboratory reference testing.
Measured: 4 months
To compare the performance of the Determine™ Syphilis Advanced test with two commercially available similar tests
The Determine™ Syphilis Advanced test will be compared with two commercially available tests. These tests are the TPPA test (SERODIA-TPPA, Fujirebio) and the Determine™ Syphilis TP (Abbott) test.
Measured: 4 months
Secondary outcomes (2)
To evaluate the usability through completion of a user experience questionnaire.
A user experience questionnaire will be completed by study healthcare staff. The users will evaluate the ease of use, and confidence in correct performance, of various test steps and result interpretation. The response options are ranked on a scale of 1-5. where option 1 stands for Very easy, or Very confident as applicable, and 5 stands for Very Difficult, or Very unsure as applicable.
Measured: 4 months
To determine the stability of venous whole blood, serum and plasma samples for use with Determine™ Syphilis Advanced, after refrigeration .
Venous whole blood, serum and plasma will be stored at 2-8 degrees Celsius during 7 days before testing with Determine™ Syphilis Advanced.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syphilis InfectionStudies 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pontiano Kaleebu, Professor, MD PhD, Principal investigator, MRC/UVRI and LSHTM Uganda Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584214
- Sponsor's protocol ID
- D10159847 (7D34VAL24-002)
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre Study to Evaluate the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.
- ClinicalTrials.gov ID
- NCT06584214
- Acronym / sponsor ID
- D10159847 (7D34VAL24-002)
- Conditions
- Syphilis Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Sep 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.
This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization\'s TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.
Detailed description
Syphilis is a sexually transmitted infection (STI) caused by the spirochete Treponema pallidum subspecies. Globally, there were an estimated 7.1 million adults between 15 and 49 years of age who acquired syphilis in 2020. Syphilis is transmitted through sexual contact with infectious lesions, through blood transfusions and from mother-to-child during pregnancy; most infections are asymptomatic or unrecognized. Without treatment, the disease lasts for many years and is divided into stages: primary syphilis, secondary syphilis and latent syphilis. Mother-to-child transmission of syphilis (congenital syphilis) can adversely affect the foetus, but this can be averted by early detection and treatment of the mother during pregnancy.
Determine™ Syphilis Advanced is an in vitro, visually read, qualitative immunoassay for the detection of antibodies to Treponema pallidum, in human capillary and venous whole blood, plasma or serum.
The test is intended for professional use, and the performance evaluation will be performed by professional healthcare and laboratory staff. Results for all sample types (capillary and venous whole blood, plasma or serum) will be evaluated against reference test results. In addition, for a sub-cohort, the Determine™ Syphilis Advanced test will be compared with the commercially available Determine™ Syphilis TP and the SERODIA-TPPA tests. Study staff performing the testing using the Determine™ Syphilis Advanced will be blinded to the participants' syphilis infection status and all other study syphilis test results. The study will enrol prospective participants, and will also have a retrospective study group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic test: Determine™ Syphilis Advanced test | Experimental | Diagnostic Test: Diagnostic test: Determine™ Syphilis Advanced testDiagnostic test: Testing using the Determine™ Syphilis Advanced test will be conducted by study staff members. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 12 years of age or older.
- The participant has confirmed previous / current syphilis according to their medical history, or the participant has unknown or negative syphilis infection status.
- The participant agrees to provide written informed consent.
- The participant agrees to complete all aspects of the study.
- The ethics committee-required written informed consent for study testing, or required documentation for sample use from a commercial vendor, is available.
Key exclusion criteria (7 listed)
- Participant has already participated in this study on a previous occasion.
- Participant is deemed vulnerable and / or unfit for participation in the study by the Investigator.
- Participant is unwilling or unable to provide informed consent.
- Participant is currently enrolled in a study to evaluate an investigational new drug or vaccine.
- Additional exclusion criteria for frozen samples
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 |
|---|---|---|
| Diagnostic test: Determine™ Syphilis Advanced testThe Determine™ Syphilis Advanced test is intended as an aid in detecting antibodies to Treponema pallidum in individuals with current or past infection. | Diagnostic test | Diagnostic test: Determine™ Syphilis Advanced test |
Primary outcome
To determine the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test results using fingerstick capillary whole blood, venous whole blood, serum and venous plasma, when the test is performed by professional users.
Time frame: 4 months
The diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test will be evaluated versus laboratory reference testing.
To compare the performance of the Determine™ Syphilis Advanced test with two commercially available similar tests
Time frame: 4 months
The Determine™ Syphilis Advanced test will be compared with two commercially available tests. These tests are the TPPA test (SERODIA-TPPA, Fujirebio) and the Determine™ Syphilis TP (Abbott) test.
2 secondary outcomes
To evaluate the usability through completion of a user experience questionnaire.
Time frame: 4 months
To determine the stability of venous whole blood, serum and plasma samples for use with Determine™ Syphilis Advanced, after refrigeration .
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Pontiano Kaleebu, Professor, MD PhD principal investigator
MRC/UVRI and LSHTM Uganda Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test: Determine™ Syphilis Advanced test in people with Syphilis Infection, run by Abbott Rapid Dx at 1 site in Uganda.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Forssten, PhD (+44 7792 902 244, camilla.forssten@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test results using fingerstick capillary whole blood, venous whole blood, serum and venous plasma, when the test is performed by professional users. (time frame: 4 months). The study lists 2 primary outcomes in all. 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 4 Sep 2024.