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:
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
  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
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

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

No publications provided

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:
Gonorrhea
Bacterial Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Infection
Neisseriaceae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial

ClinicalTrials.gov processed this record on February 08, 2016