Syphilis InfectionNCT05063344
NOWDx Test for the Diagnosis of Syphilis
An observational study of Syphilis Infection and Treponema Pallidum Infection, run by NOWDiagnostics, Inc. at 6 sites in United States.
Trial summary
This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Syphilis Infection, Treponema Pallidum Infection
- What is being tested?
- Diagnostic Test: NOWDx Syphilis Test
- Type of treatment
- Medical device
- How many people
- 1,535 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Oct 2021to 11 Dec 2023
- Phase
- Observational
- 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 18 to 64 years
- All sexes
- Adult
Study population: Residents of the U.S. who elect to participate in the study
Who may be able to join
- sexually active persons 18-64 years old
- expectant mothers ≥18 years old
- persons 18-64 years old;
- -½ high risk sexual behavior; ½ low risk sexual behavior
Who cannot join
- persons <18 years old; persons >64 years old;
- persons with limited or no reading skills;
- persons who previously participated in a NOWDx study
- Expectant mothers
- n=222 participants; ~74 per study site
- persons <18 years old;
Show all 13Show fewer
- persons with limited or no reading skills;
- persons who previously participated in a NOWDx study
- Lay users
- n=48 participants; ~16 per study site
- persons <18 years old; persons >64 years old;
- persons with limited or no reading skills;
- persons who previously participated in a NOWDx study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Multicare Rockwood
Cheney, Washington, 99004
AMR Las Vegas
Las Vegas, Nevada, 89119
Matrix Clinical Research
Los Angeles, California, 90057
Segal Trials
North Miami, Florida, 33161
AMR Tempe
Tempe, Arizona, 85281
People Care Institute
West Orange, New Jersey, 07052
About this study
This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx Syphilis Test is intended for qualitatively detecting the presence or absence of human antibodies to syphilis in human whole blood to aid in the diagnosis of infection caused by Treponema pallidum.
Read the detailed description
The objective of this study is to establish the performance characteristics of the NOWDx Syphilis Test based on comparison to the BioRad Bioplex 2200 series Syphilis Total (IgG/IgM), Wampole Impact RPR Test Kit, and to the Serodia Treponema pallidum particle agglutination assay (TP-PA).
The external clinical study along with in-house analytical studies will demonstrate the efficacy of the NOWDx Syphilis Test as an aid in the diagnosis of syphilis infection for at home testing and point of care testing sites. Participants will self test and be tested by Clinical Laboratory Improvement Amendments (CLIA) Waived operators with the NOWDx Syphilis Test at independent sites in WA, AZ, and NV. Two sample types will be tested with the NOWDx Syphilis Test for each participant: fingerstick whole blood and venous whole blood. Sera from each participant will be tested at an independent reference laboratory.
The NOWDx Syphilis Test will be evaluated in diverse populations of sexually active persons who self-select for syphilis testing and expectant mothers.
- Conditions
- Syphilis Infection, Treponema Pallidum Infection
- Being tested
- Diagnostic Test: NOWDx Syphilis Test
- Keywords
- Syphilis, Treponema Pallidum
- Medical subject headings
- Syphilis, Treponemal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: NOWDx Syphilis TestDevice
For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.
| Study group | Role | What they receive |
|---|---|---|
| Sexually active persons who self-select for syphilis testing | Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years Receives: Device: Diagnostic Test: NOWDx Syphilis Test | |
| Expectant mothers | Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years Receives: Device: Diagnostic Test: NOWDx Syphilis Test | |
| Lay users | Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years; 1/2 high risk sexual behavior and 1/2 low risk sexual behavior Receives: Device: Diagnostic Test: NOWDx Syphilis Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare serological status to comparator method
The comparator method used in this study is an algorithm comprised of results from three different commercially available syphilis assays: an FDA-cleared treponemal immunoassay, an FDA-cleared non-treponemal assay (RPR assay) and a second treponemal assay (TP-PA).
Measured: through study completion, an average of 6 months
Evaluate test reproducibility by lay users
Test lay user reproducibility using prepared samples for % agreement with expected results.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start4 Oct 2021
- Primary completion17 Oct 2023
- Study completion11 Dec 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,535 participants (actual)
Sponsor and investigators
- Lead sponsor
- NOWDiagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Rabine, MS, Study director, NOW Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063344
- Sponsor's protocol ID
- NOWDx Syphilis Study
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOWDx Test for the Diagnosis of Syphilis
- ClinicalTrials.gov ID
- NCT05063344
- Acronym / sponsor ID
- NOWDx Syphilis Study
- Conditions
- Syphilis Infection, Treponema Pallidum Infection
- Keywords
- Syphilis, Treponema Pallidum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,535 participants (actual)
- Lead sponsor
- NOWDiagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 1 Oct 2021 (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 study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx Syphilis Test is intended for qualitatively detecting the presence or absence of human antibodies to syphilis in human whole blood to aid in the diagnosis of infection caused by Treponema pallidum.
Detailed description
The objective of this study is to establish the performance characteristics of the NOWDx Syphilis Test based on comparison to the BioRad Bioplex 2200 series Syphilis Total (IgG/IgM), Wampole Impact RPR Test Kit, and to the Serodia Treponema pallidum particle agglutination assay (TP-PA).
The external clinical study along with in-house analytical studies will demonstrate the efficacy of the NOWDx Syphilis Test as an aid in the diagnosis of syphilis infection for at home testing and point of care testing sites. Participants will self test and be tested by Clinical Laboratory Improvement Amendments (CLIA) Waived operators with the NOWDx Syphilis Test at independent sites in WA, AZ, and NV. Two sample types will be tested with the NOWDx Syphilis Test for each participant: fingerstick whole blood and venous whole blood. Sera from each participant will be tested at an independent reference laboratory.
The NOWDx Syphilis Test will be evaluated in diverse populations of sexually active persons who self-select for syphilis testing and expectant mothers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sexually active persons who self-select for syphilis testing | – | Device: Diagnostic Test: NOWDx Syphilis TestParticipants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years |
| Expectant mothers | – | Device: Diagnostic Test: NOWDx Syphilis TestParticipants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years |
| Lay users | – | Device: Diagnostic Test: NOWDx Syphilis TestParticipants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years; 1/2 high risk sexual behavior and 1/2 low risk sexual behavior |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- Residents of the U.S. who elect to participate in the study
Key inclusion criteria (4 listed)
Key exclusion criteria (13 listed)
- Expectant mothers
- Lay users
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: NOWDx Syphilis TestFor this observational trial, the Intervention of interest is the NOWDx Syphilis Test. | Device | Expectant mothers, Lay users, Sexually active persons who self-select for syphilis testing |
Primary outcome
Compare serological status to comparator method
Time frame: through study completion, an average of 6 months
The comparator method used in this study is an algorithm comprised of results from three different commercially available syphilis assays: an FDA-cleared treponemal immunoassay, an FDA-cleared non-treponemal assay (RPR assay) and a second treponemal assay (TP-PA).
Evaluate test reproducibility by lay users
Time frame: through study completion, an average of 6 months
Test lay user reproducibility using prepared samples for % agreement with expected results.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 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.
Sharon Rabine, MS study director
NOW Diagnostics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syphilis Infection and Treponema Pallidum Infection, run by NOWDiagnostics, Inc. at 6 sites in United States.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 29 Feb 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare serological status to comparator method (time frame: through study completion, an average of 6 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 29 Feb 2024.