Clinical trial NCT01167777: Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
Official title: Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chlamydia
Gonorrhea
Keywords: CT
GC
NG
chlamydia
gonorrhoeae
Lead sponsor: Siemens Healthcare Diagnostics Inc
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 2296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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 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.

Primary outcomes:
measure: Prevalence of CT and/or GC disease by clinical site
timeFrame: Study terminated
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Los Angeles County Department of Public Health
state: California
city: San Francisco
country: United States
facility: San Francisco Dept of Public Health
state: California
city: Stockton
country: United States
facility: San Joaquin County Public Health Services
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Siemens Healthcare Diagnostics
name: NORMAND DESPRES, PhD
role: STUDY_DIRECTOR
References: