ChlamydiaNCT01167777
Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
An observational study of Chlamydia and Gonorrhea, run by Siemens Healthcare Diagnostics Inc at 7 sites in United States.
Trial summary
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- How many people
- 2,296 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2010to Dec 2010
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic and asymptomatic male and female patients attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC
Who may be able to join
- Subject is 18 years of age or older.
- Subject signed an IRB approved informed consent form.
- Subject is able to follow verbal and written instructions.
Who cannot join
- Subject has been on antibiotic therapy within 21 days prior to study enrollment.
- Subject urinated within one hour prior to sample collection.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama At Birmingham
Birmingham, Alabama, 35294
Indiana University
Indianapolis, Indiana, 46202
Los Angeles County Department of Public Health
Los Angeles, California, 90007
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
San Francisco Dept of Public Health
San Francisco, California, 94103
San Joaquin County Public Health Services
Stockton, California, 95205
About this study
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).
Read the detailed description
The study was terminated
This clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the VERSANT CT/GC DNA 1.0 (kPCR) Assay for product registration. The Gen-Probe APTIMA Combo 2 Assay will be used as the CE-marked comparative method. The studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness, as well as the labeling claims for the VERSANT CT/GC Assay. The study objectives are as follows:
- To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay;
- To estimate the positive and negative predictive values for each specimen type included in the study;
- To estimate the indeterminate rate for each specimen type included in the study;
- To estimate the equivocal rate for each specimen type; and
- To assess reproducibility of the VERSANT CT/CG DNA 1.0 Assay (kPCR) using the VERSANT kPCR Molecular System.
Two (2) studies will be conducted to validate the analytical and clinical performance characteristics of the CT/GC DNA 1.0 (kPCR) Assay. Table 1 provides an overview of these studies.
- Keywords
- CT, GC, NG, chlamydia, gonorrhoeae
- Medical subject headings
- Chlamydia Infections, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| male/female | Symtomatic and asymptomatic males and females attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CT and/or GC disease by clinical site
Measured: Study terminated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Siemens Management decided not to release the product in the USA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlamydiaStudies 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
- 2,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthcare Diagnostics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- NORMAND DESPRES, PhD, Study director, Siemens Healthcare Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167777
- Sponsor's protocol ID
- MCSA-VkPCRCTGC-200810-PRO
- Status last verified
- Nov 2015
- First submitted
- 21 Jul 2010
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
- ClinicalTrials.gov ID
- NCT01167777
- Acronym / sponsor ID
- MCSA-VkPCRCTGC-200810-PRO
- Keywords
- CT, GC, NG, chlamydia, gonorrhoeae
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Siemens Management decided not to release the product in the USA.
- Enrolment
- 2,296 participants (actual)
- Lead sponsor
- Siemens Healthcare Diagnostics IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jul 2010 (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.
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).
Detailed description
The study was terminated
This clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the VERSANT CT/GC DNA 1.0 (kPCR) Assay for product registration. The Gen-Probe APTIMA Combo 2 Assay will be used as the CE-marked comparative method. The studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness, as well as the labeling claims for the VERSANT CT/GC Assay. The study objectives are as follows:
- To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay;
- To estimate the positive and negative predictive values for each specimen type included in the study;
- To estimate the indeterminate rate for each specimen type included in the study;
- To estimate the equivocal rate for each specimen type; and
- To assess reproducibility of the VERSANT CT/CG DNA 1.0 Assay (kPCR) using the VERSANT kPCR Molecular System.
Two (2) studies will be conducted to validate the analytical and clinical performance characteristics of the CT/GC DNA 1.0 (kPCR) Assay. Table 1 provides an overview of these studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| male/female | – | –Symtomatic and asymptomatic males and females attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic and asymptomatic male and female patients attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC
Key inclusion criteria (3 listed)
- Subject is 18 years of age or older.
- Subject signed an IRB approved informed consent form.
- Subject is able to follow verbal and written instructions.
Key exclusion criteria (2 listed)
- Subject has been on antibiotic therapy within 21 days prior to study enrollment.
- Subject urinated within one hour prior to sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of CT and/or GC disease by clinical site
Time frame: Study terminated
Results and safety
The study was stopped early (reason given: Siemens Management decided not to release the product in the USA.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
Related trials for Chlamydia
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
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.
NORMAND DESPRES, PhD study director
Siemens Healthcare Diagnostics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydia and Gonorrhea, run by Siemens Healthcare Diagnostics Inc at 7 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 was stopped early (reason given: Siemens Management decided not to release the product in the USA.). Results are not available in the source record.
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?
Prevalence of CT and/or GC disease by clinical site (time frame: Study terminated). 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 26 Nov 2015.