Prospective Collection of Female and Male Specimens for PANTHER® System Testing
- Conditions
- Chlamydia InfectionsGonorrhea
- Interventions
- Device: APTIMA Assays; PANTHER System
- Registration Number
- NCT01638637
- Lead Sponsor
- Gen-Probe, Incorporated
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1492
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Specimen Collection APTIMA Assays; PANTHER System -
- Primary Outcome Measures
Name Time Method 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 approximately one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
John Hopkins University
🇺🇸Baltimore, Maryland, United States
Laboratory Corporation of America
🇺🇸Burlington, North Carolina, United States
Molecular Pathology Laboratory Network, Inc.
🇺🇸Maryville, Tennessee, United States
Anthony Mills MD Inc.
🇺🇸Los Angeles, California, United States
New England Center for Clinical Research - New Bedford Clinic
🇺🇸New Bedford, Massachusetts, United States
Tidewater Clinical Research, Inc. -Tidewater Physicians for Women
🇺🇸Norfolk, Virginia, United States
Planned Parenthood Houston and Southeast Texas
🇺🇸Houston, Texas, United States
Louisiana State University Health Sciences
🇺🇸New Orleans, Louisiana, United States
Benchmark Research
🇺🇸San Francisco, California, United States
University of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Planned Parenthood Southern New England
🇺🇸New Haven, Connecticut, United States
Wishard Health Services
🇺🇸Indianapolis, Indiana, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States