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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Siemens Healthcare Diagnostics Inc.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Siemens Healthcare Diagnostics Inc
ClinicalTrials.gov Identifier:
NCT01167777
First received: July 21, 2010
Last updated: August 28, 2010
Last verified: August 2010
  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:

Estimated Enrollment: 3000
Study Start Date: August 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: VALERIE NGUYEN, MS 510.982.4123 valerie.nguyen@siemens.com
Contact: NORMAND DESPRES, PhD 914.524.2680 normand.despres@siemens.com

Locations
United States, Alabama
University of Alabama At Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: CONNIE LENDERMAN, MBA, MT(ASCP)       clende@uab.edu   
Principal Investigator: EDWARD W HOOK III, MD         
United States, California
Los Angeles County Department of Public Health Not yet recruiting
Los Angeles, California, United States, 90007
Contact: APURVA UNIYAL       auniyal@ph.lacounty.gov   
Principal Investigator: PETER KERNDT, MD, MPH         
San Francisco Dept of Public Health Not yet recruiting
San Francisco, California, United States, 94103
Contact: Hanna Hjord, MPH       Hanna.Hjord@sfdph.org   
Principal Investigator: SUSAN PHILIP, MD, MPH         
San Joaquin County Public Health Services Recruiting
Stockton, California, United States, 95205
Contact: DIANE SCHULTZ       dschultz@sjcphs.org   
Principal Investigator: STEPHEN A WILLIS         
United States, Indiana
Indiana University Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: DEANNA FULLER, MS, MT(ASCP)       dfuller@iupui.edu   
Principal Investigator: THOMAS E DAVIS, MD PhD         
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: MATHILDA BARNES       mbarnes2@jhmi.edu   
Principal Investigator: CHARLOTTE GAYDOS, DrPH         
United States, Minnesota
Hennepin County Medical Center Not yet recruiting
Minneapolis, Minnesota, United States, 55415
Contact: KEVAN HANSEN       kevan.hanson@hcmed.org   
Principal Investigator: GLEN HANSEN, PhD         
Sponsors and Collaborators
Siemens Healthcare Diagnostics Inc
  More Information

No publications provided

Responsible Party: Valerie Nguyen, Senior Manager, Clinical Affairs, 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: August 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Siemens Healthcare Diagnostics Inc:
CT
GC
NG
chlamydia
gonorrhoeae

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

ClinicalTrials.gov processed this record on September 18, 2014