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

Gen-Probe, Incorporated16 sites in 1 country1,492 target enrollmentFebruary 2012

ConditionsChlamydia Infections Gonorrhea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chlamydia Infections
Sponsor: Gen-Probe, Incorporated
Enrollment: 1492
Locations: 16
Primary Endpoint: 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
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

July 2013

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Gen-Probe, Incorporated

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: approximately one year