Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System

NCT01358799 | Withdrawn

• 1 other identifier: ACTPS-US10-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Conditions

Chlamydia Trachomatis

Keywords

Chlamydia trachomatis; APTIMA Assay for Chlamydia trachomatis

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference

  Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference

  approximately one year

Secondary Outcomes (1)

• Positivity Rate

  approximately one year

Interventions

APTIMA Assay for Chlamydia trachomatis DEVICE

APTIMA Assay for Chlamydia trachomatis

Also known as: Chlamydia trachomatis

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and Females at least 14 years of age at the time of informed consent and sexually active.

You may qualify if:

• The subject is at least 14 years of age at the time of informed consent and is sexually active
• The subject reports symptoms consistent with a suspected STD such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort.
• If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam
• The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an IRBapproved waiver for parental consent for minors)

You may not qualify if:

• A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
• The subject took antibiotic medications within the last 21 days
• The subject is underage (as defined by the IRB or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors)
• The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.

Sponsors & Collaborators

• Gen-Probe, Incorporated: lead

Study Sites (7)

Wishard Health Services Department of Pathology Wishard Health Services

Indianapolis, Indiana, 46202, United States

Location

Louisianna State University Health Center

New Orleans, Louisiana, 92122, United States

Location

New England Center for Clinical Research

Fall River, Massachusetts, 02720, United States

Location

University of North Carolina Chapel Hill STD Clinic

Chapel Hill, North Carolina, 27599, United States

Location

Planned Parenthood Northeast Ohio

Akron, Ohio, 44302, United States

Location

Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology

Cincinnati, Ohio, 45229, United States

Location

Planned Parenthood Houston and Southeast Texas

Houston, Texas, 77023, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

4 specimens will be collected from each female subject in the following order: 1 first-catch urine specimen, 1 vaginal swab specimen (patient or clinician-collected), 1 cervical specimen (using a broomlike collection device or a brush/spatula combination), and 1 endocervical swab specimen. An additional cervical specimen may be collected from female subjects for other clinical trial purposes or research studies. Up to 2 specimens will be collected from each male subject in the following order: 1 urethral swab specimen and 1 first-catch urine specimen.

Study Officials

• Jennifer Reid, PhD

  Gen-Probe, Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

US (7)