Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae

November 24, 2015 updated by: Siemens Healthcare Diagnostics Inc
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).

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

2296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90007
        • Los Angeles County Department of Public Health
      • San Francisco, California, United States, 94103
        • San Francisco Dept of Public Health
      • Stockton, California, United States, 95205
        • San Joaquin County Public Health Services
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of CT and/or GC disease by clinical site
Time Frame: Study terminated
Study terminated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siemens Healthcare Diagnostics Inc

Investigators

  • Study Director: NORMAND DESPRES, PhD, Siemens Healthcare Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Estimate)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 24, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCSA-VkPCRCTGC-200810-PRO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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