Study Stopped
Sponsor business decision
Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
1 other identifier
observational
1,766
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Shorter than P25 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedStudy Start
First participant enrolled
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 24, 2017
March 1, 2017
8 months
June 2, 2016
March 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity
Enrollment ongoing until estimated March 2017
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hologic, Inc.lead
Study Sites (18)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Planned Parenthood of Southern New England, Inc
New Haven, Connecticut, 06511, United States
Segal Institute for Clinical Research
Miami, Florida, 33161, United States
Eskenazi Hospital - Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Clinical Trials Management, LLC
Mandeville, Louisiana, 70471, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
LabCorp
Burlington, North Carolina, 27215, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Multnomah County Health Department, STD Clinic
Portland, Oregon, 97204, United States
Geneuity
Maryville, Tennessee, 37804, United States
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, 77023, United States
Brownstone Clinical Trials
Irving, Texas, 75062, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Tidewater Clinical Research, Inc.
Virginia Beach, Virginia, 23456, United States
University of Washington Center for AIDS & STD
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 10, 2016
Study Start
June 30, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 24, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share