SyphilisNCT00300534
Multi-site Study of Rapid Diagnostic Syphilis Assays
A study testing Abbott Laboratories Determine test for syphilis and Investigational syphilis immunochromatographic strip test in people with Syphilis, run by Centers for Disease Control and Prevention at 5 sites in United States.
Trial summary
The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syphilis
- What is being tested?
- Abbott Laboratories Determine test for syphilis and Investigational syphilis immunochromatographic strip test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2002to Jul 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive patients
Who cannot join
- Less than age 18 years
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Fulton County Department of Health
Atlanta, Georgia
Chicago Department of Public Health
Chicago, Illinois, 60616
Bell Flower Clinic
Indianapolis, Indiana, 46202
Los Angeles Department of Health Services
Los Angeles, California
New York City Department of Health
New York, New York
About this study
Official title: Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas
The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.
- Conditions
- Syphilis
- Being tested
- Abbott Laboratories Determine test for syphilis, Investigational syphilis immunochromatographic strip test
- Keywords
- Diagnosis
- Medical subject headings
- Syphilis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott Laboratories Determine test for syphilisDevice
Investigational syphilis immunochromatographic strip testDevice
| Study group | Role | What they receive |
|---|---|---|
| Abbott Laboratories Determine test for syphilis | No intervention | Abbott Laboratories Determine rapid test for syphilis Receives: Device: Abbott Laboratories Determine test for syphilis; Device: Investigational syphilis immunochromatographic strip test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Treponema pallidum infection
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startAug 2002
- Primary completionDec 2005
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robert E. Johnson, MD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300534
- Sponsor's protocol ID
- CDC-NCHSTP-2875
- Status last verified
- Sep 2012
- First submitted
- 2 Mar 2006
- Last updated
- 7 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas
- ClinicalTrials.gov ID
- NCT00300534
- Acronym / sponsor ID
- CDC-NCHSTP-2875
- Conditions
- Syphilis
- Keywords
- Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Aug 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Mar 2006 (estimated)
- 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 performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abbott Laboratories Determine test for syphilis | No intervention | Device: Abbott Laboratories Determine test for syphilis, Device: Investigational syphilis immunochromatographic strip testAbbott Laboratories Determine rapid test for syphilis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients
Key exclusion criteria (1 listed)
- Less than age 18 years
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 |
|---|---|---|
| Abbott Laboratories Determine test for syphilis | Device | Abbott Laboratories Determine test for syphilis |
| Investigational syphilis immunochromatographic strip test | Device | Abbott Laboratories Determine test for syphilis |
Primary outcome
Diagnosis of Treponema pallidum infection
Time frame: 7 days
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 7 Sep 2012.
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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.
Robert E. Johnson, MD, MPH principal investigator
Centers for Disease Control and Prevention
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott Laboratories Determine test for syphilis and Investigational syphilis immunochromatographic strip test in people with Syphilis, run by Centers for Disease Control and Prevention at 5 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 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: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Diagnosis of Treponema pallidum infection (time frame: 7 days). 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 7 Sep 2012.