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

March 22, 2017 updated by: Hologic, Inc.
The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

1766

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The University of Alabama at Birmingham
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Planned Parenthood of Southern New England, Inc
    • Florida
      • Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Eskenazi Hospital - Indiana University School of Medicine
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Clinical Trials Management, LLC
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research, Inc.
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • LabCorp
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97204
        • Multnomah County Health Department, STD Clinic
    • Tennessee
      • Maryville, Tennessee, United States, 37804
        • Geneuity
    • Texas
      • Houston, Texas, United States, 77023
        • Planned Parenthood Gulf Coast, Inc.
      • Irving, Texas, United States, 75062
        • Brownstone Clinical Trials
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Tidewater Clinical Research, Inc.
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington Center for AIDS & STD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Sexually active women ≥14 years of age with or without symptoms of STIs will be eligible for enrollment. Participating clinical collection sites may include US family planning, public health, and STI clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity
Time Frame: Enrollment ongoing until estimated March 2017
Enrollment ongoing until estimated March 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A10417-AC2PS-CSP-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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