Prospective Collection of Female and Male Specimens for PANTHER® System Testing (NCT01638637) | Clinical Trial Compass
CompletedNot Applicable
Prospective Collection of Female and Male Specimens for PANTHER® System Testing
United States1,492 participantsStarted 2012-02
Plain-language 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
Who can participate
Age range16 Years
SexALL
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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 compl…
What they're measuring
1
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