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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chlamydia Trachomatis
• Intervention / Treatment: Device: APTIMA Assay for Chlamydia trachomatis

Detailed Description

This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis) Assay. Instead, testing was conducted and results were generated with the Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended by the RRS team per their email to me on 8 February 2013.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Wishard Health Services Department of Pathology Wishard Health Services
  • Louisiana
    • New Orleans, Louisiana, United States, 92122
      • Louisianna State University Health Center
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Chapel Hill STD Clinic
  • Ohio
    • Akron, Ohio, United States, 44302
      • Planned Parenthood Northeast Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
  • Texas
    • Houston, Texas, United States, 77023
      • Planned Parenthood Houston and Southeast Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positivity Rate	Positivity Rate	approximately one year

Collaborators and Investigators

• Sponsor: Gen-Probe, Incorporated

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 12, 2013
• Last Update Submitted That Met QC Criteria: March 8, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Chlamydia trachomatis; APTIMA Assay for Chlamydia trachomatis
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections
• Other Study ID Numbers: ACTPS-US10-001 (Gen-Probe)