Clinical trial NCT02795975: Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
Official title: Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chlamydia Trachomatis
Gonorrhea
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-10
Enrollment: 1766
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: Enrollment ongoing until estimated March 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: New Haven
country: United States
facility: Planned Parenthood of Southern New England, Inc
state: Connecticut
city: Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Eskenazi Hospital - Indiana University School of Medicine
state: Indiana
city: Mandeville
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Burlington
country: United States
facility: LabCorp
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Multnomah County Health Department, STD Clinic
state: Oregon
city: Maryville
country: United States
facility: Geneuity
state: Tennessee
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast, Inc.
state: Texas
city: Irving
country: United States
facility: Brownstone Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: University of Washington Center for AIDS & STD
state: Washington
Study officials:
References: