Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
This study has been terminated.
(Siemens Management decided not to release the product in the USA.)
Sponsor:
Siemens Healthcare Diagnostics Inc
Information provided by (Responsible Party):
Siemens Healthcare Diagnostics Inc
ClinicalTrials.gov Identifier:
NCT01167777
First received: July 21, 2010
Last updated: November 24, 2015
Last verified: November 2015
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Purpose
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).
| Condition |
|---|
|
Chlamydia Gonorrhea |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae |
Resource links provided by NLM:
Further study details as provided by Siemens Healthcare Diagnostics Inc:
Primary Outcome Measures:
- Prevalence of CT and/or GC disease by clinical site [ Time Frame: Study terminated ] [ Designated as safety issue: No ]
| Enrollment: | 2296 |
| Study Start Date: | August 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subject has been on antibiotic therapy within 21 days prior to study enrollment.
- Subject urinated within one hour prior to sample collection.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167777
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167777
Locations
| United States, Alabama | |
| University of Alabama At Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Los Angeles County Department of Public Health | |
| Los Angeles, California, United States, 90007 | |
| San Francisco Dept of Public Health | |
| San Francisco, California, United States, 94103 | |
| San Joaquin County Public Health Services | |
| Stockton, California, United States, 95205 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Minnesota | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States, 55415 | |
Sponsors and Collaborators
Siemens Healthcare Diagnostics Inc
Investigators
| Study Director: | NORMAND DESPRES, PhD | Siemens Healthcare Diagnostics |
More Information
| Responsible Party: | Siemens Healthcare Diagnostics Inc |
| ClinicalTrials.gov Identifier: | NCT01167777 History of Changes |
| Other Study ID Numbers: | MCSA-VkPCRCTGC-200810-PRO |
| Study First Received: | July 21, 2010 |
| Last Updated: | November 24, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Siemens Healthcare Diagnostics Inc:
|
CT GC NG chlamydia gonorrhoeae |
Additional relevant MeSH terms:
|
Chlamydia Infections Gonorrhea Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial |
Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Neisseriaceae Infections |
ClinicalTrials.gov processed this record on September 27, 2016