Clinical trial NCT01638637: Prospective Collection of Female and Male Specimens for PANTHER® System Testing
Official title: Prospective Collection of Female First-catch Urine, Vaginal Swab, Cervical, and Endocervical Swab Specimens and Male Urethral Swab and First-catch Urine Specimens for Testing With the PANTHER® System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chlamydia Infections
Gonorrhea
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 1492
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Symptomatic and asymptomatic subjects at least 16 years of age.

Brief summary: The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System


Eligibility criteria: Inclusion Criteria:

* The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had intercourse within the past 12 months)
* The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board (IRB)-approved waiver for parental consent for minors)

In addition, the subject must meet at least one of the following criteria:

* The subject reports symptoms consistent with a suspected STI such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
* Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
* Subject is asymptomatic and undergoing screening evaluation for possible STIs
* Subject (female) is asymptomatic and undergoing a routine examination with a pelvic examination

Exclusion Criteria:

* A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
* The subject took antibiotic medications within the last 21 days
* Subject already participated in this study
* Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
* Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled

Primary outcomes:
measure: Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
timeFrame: approximately one year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Anthony Mills MD Inc.
state: California
city: San Francisco
country: United States
facility: Benchmark Research
state: California
city: New Haven
country: United States
facility: Planned Parenthood Southern New England
state: Connecticut
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Indianapolis
country: United States
facility: Wishard Health Services
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: New Bedford
country: United States
facility: New England Center for Clinical Research - New Bedford Clinic
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Burlington
country: United States
facility: Laboratory Corporation of America
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Maryville
country: United States
facility: Molecular Pathology Laboratory Network, Inc.
state: Tennessee
city: Houston
country: United States
facility: Planned Parenthood Houston and Southeast Texas
state: Texas
city: Norfolk
country: United States
facility: Tidewater Clinical Research, Inc. -Tidewater Physicians for Women
state: Virginia
Study officials:
affiliation: Gen-Probe, Incorporated
name: Jennifer Reid, PhD
role: STUDY_DIRECTOR
References: