Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
- Conditions
- Chlamydia InfectionsGonorrheaTrichomonas Infections
- Interventions
- Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
- Registration Number
- NCT01728103
- Lead Sponsor
- Gen-Probe, Incorporated
- Brief Summary
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 1336
- The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/vaginal 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 sexually transmissible infection (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 is asymptomatic and undergoing a routine examination with a pelvic examination
- 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 No Treatment APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays -
- Primary Outcome Measures
Name Time Method Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease approximately one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
John Hopkins University
🇺🇸Baltimore, Maryland, United States
Planned Parenthood Southeastern Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
🇺🇸Cincinnati, Ohio, United States
Tidewater Clinical Research
🇺🇸Norfolk, Virginia, United States
Planned Parenthood Gulf Coast
🇺🇸Houston, Texas, United States
Mount Vernon Clinical Research
🇺🇸Sandy Springs, Georgia, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Healthcare Clinical Data
🇺🇸North Miami, Florida, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
New England Center for Clinical Research
🇺🇸Fall River, Massachusetts, United States
Infectious Diseases STD Program University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States