Study Stopped
Siemens Management decided not to release the product in the USA.
Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
1 other identifier
observational
2,296
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedNovember 26, 2015
November 1, 2015
4 months
July 21, 2010
November 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of CT and/or GC disease by clinical site
Study terminated
Study Arms (1)
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.
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- Subject has been on antibiotic therapy within 21 days prior to study enrollment.
- Subject urinated within one hour prior to sample collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Los Angeles County Department of Public Health
Los Angeles, California, 90007, United States
San Francisco Dept of Public Health
San Francisco, California, 94103, United States
San Joaquin County Public Health Services
Stockton, California, 95205, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
NORMAND DESPRES, PhD
Siemens Healthcare Diagnostics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 22, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 26, 2015
Record last verified: 2015-11