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

Terminated

• Conditions: Chlamydia Trachomatis; Gonorrhea

• Registration Number: NCT02795975
• Lead Sponsor: Hologic, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Study Start: 2016-06-30
• Status Verified: 2017-03
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1766

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity	Enrollment ongoing until estimated March 2017

Trial Locations

Locations (18)

Geneuity; 🇺🇸 Maryville, Tennessee, United States

Brownstone Clinical Trials; 🇺🇸 Irving, Texas, United States

LabCorp; 🇺🇸 Burlington, North Carolina, United States

Quality Clinical Research, Inc.; 🇺🇸 Omaha, Nebraska, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Beyer Research; 🇺🇸 Kalamazoo, Michigan, United States

Planned Parenthood Gulf Coast, Inc.; 🇺🇸 Houston, Texas, United States

Tidewater Clinical Research, Inc.; 🇺🇸 Virginia Beach, Virginia, United States

University of Washington Center for AIDS & STD; 🇺🇸 Seattle, Washington, United States

Eskenazi Hospital - Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Segal Institute for Clinical Research; 🇺🇸 Miami, Florida, United States

Planned Parenthood of Southern New England, Inc; 🇺🇸 New Haven, Connecticut, United States

Clinical Trials Management, LLC; 🇺🇸 Mandeville, Louisiana, United States

Multnomah County Health Department, STD Clinic; 🇺🇸 Portland, Oregon, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States