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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease
Chlamydia; Gonorrhea

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

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Study Type :	Observational
Actual Enrollment :	2296 participants
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
Study Start Date :	August 2010
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Groups and Cohorts

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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.

Outcome Measures

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Primary Outcome Measures :

1. Prevalence of CT and/or GC disease by clinical site [ Time Frame: Study terminated ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Siemens Healthcare Diagnostics Inc
ClinicalTrials.gov Identifier:	NCT01167777 History of Changes
Other Study ID Numbers:	MCSA-VkPCRCTGC-200810-PRO
First Posted:	July 22, 2010
Last Update Posted:	November 26, 2015
Last Verified:	November 2015

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