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

Gonorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01167777
• Other study ID #: MCSA-VkPCRCTGC-200810-PRO
• Status: Terminated
• Phase: N/A
• First received: July 21, 2010
• Last updated: November 24, 2015
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: November 2015
• Source: Siemens Healthcare Diagnostics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2296
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama At Birmingham	Birmingham	Alabama
United States	Indiana University	Indianapolis	Indiana
United States	Los Angeles County Department of Public Health	Los Angeles	California
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	San Francisco Dept of Public Health	San Francisco	California
United States	San Joaquin County Public Health Services	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Siemens Healthcare Diagnostics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of CT and/or GC disease by clinical site		Study terminated	No