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

Stopped early

Conditions studied: Chlamydia Trachomatis, Gonorrhea

In brief

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

Key facts

Study ID

NCT02795975

Run by

Hologic, Inc.

People needed

1766

Starts

2016-06-30

Expected to finish

2017-03-01

Last updated by the study team

2017-03-24

Who can join

Age: 14 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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