Prospective Collection of Female and Male Specimens for PANTHER® System Testing

Gen-Probe

Status: Completed

Conditions: Gonorrhea; Chlamydia Infections

Treatments: Device: APTIMA Assays; PANTHER System

Study type: Observational

Funder types: Industry

Identifiers

NCT01638637

AGCPS-US11-002

AC2PS-US12-001 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,492 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,492 participants in 1 patient group

Specimen Collection

Treatment:

Device: APTIMA Assays; PANTHER System