Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System

Chlamydia Trachomatis Clinical Trial

Official title:

Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733069
• Other study ID #: AC2PS-US11-001
• Secondary ID: ACTPS-US10-001
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: November 26, 2013
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: November 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 objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.

Description:

The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from protocol ACTPS-US10-001(NCT01358799).

The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1912
• Est. completion date: February 2012
• Est. primary completion date: February 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 (sexually transmitted disease) 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 IRB (institutional review board) approved 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 (institutional review board) 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 Trachomatis
• Gonorrhea
• Neisseria Gonorrhoeae Infection

Intervention

Device:
• APTIMA COMBO 2 Assay (AC2 Assay)
APTIMA COMBO 2 Assay (AC2 Assay

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	Louisiana 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	APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type	Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)	Baseline	No