Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples

Gonorrhea Clinical Trial

Official title:

Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02795975
• Other study ID #: A10417-AC2PS-CSP-02
• Status: Terminated
• Phase: N/A
• First received: June 2, 2016
• Last updated: March 22, 2017
• Start date: June 30, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1766
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• The subject is =14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months).

• For subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (IRB).

• The subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and:

• reports symptoms consistent with a suspected STI (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or

• is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI; or

• is asymptomatic and undergoing screening evaluation for possible STIs; or

• is asymptomatic and undergoing a routine pelvic examination.

Exclusion Criteria:

• The subject took antibiotic medications within the last 21 days prior to collection.

• The subject already participated in the study.

• The subject has a history of illness that the PI or designee considers could interfere with or affect the conduct, results, and/or completion of the study.

Related Conditions & MeSH terms

• Chlamydia Trachomatis
• Gonorrhea

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	LabCorp	Burlington	North Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Planned Parenthood Gulf Coast, Inc.	Houston	Texas
United States	Eskenazi Hospital - Indiana University School of Medicine	Indianapolis	Indiana
United States	Brownstone Clinical Trials	Irving	Texas
United States	Beyer Research	Kalamazoo	Michigan
United States	Clinical Trials Management, LLC	Mandeville	Louisiana
United States	Geneuity	Maryville	Tennessee
United States	Segal Institute for Clinical Research	Miami	Florida
United States	Planned Parenthood of Southern New England, Inc	New Haven	Connecticut
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Multnomah County Health Department, STD Clinic	Portland	Oregon
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	University of Washington Center for AIDS & STD	Seattle	Washington
United States	Tidewater Clinical Research, Inc.	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity		Enrollment ongoing until estimated March 2017