Chlamydia Infections, Gonorrhea
Conditions
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
Interventions
DEVICEAPTIMA Assays; PANTHER System
APTIMA Assays; PANTHER System
Sponsors
Gen-Probe, Incorporated
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed