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

Chlamydia Trachomatis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01358799
• Other study ID #: ACTPS-US10-001
• Status: Withdrawn
• Phase: N/A
• First received: May 20, 2011
• Last updated: March 8, 2013
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: March 2013
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis)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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis

Intervention

Device:
• APTIMA Assay for Chlamydia trachomatis
APTIMA Assay for Chlamydia trachomatis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Positivity Rate	Positivity Rate	approximately one year	No