Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays

Terminated

• Conditions: Chlamydia Infections; Gonorrhea; Trichomonas Infections

• 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

Study Timeline

• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-16
• Study Start: 2013-01
• Primary Completion: 2014-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1336

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Trial Locations

Locations (14)

Infectious Diseases STD Program University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Healthcare Clinical Data; 🇺🇸 North Miami, Florida, United States

Mount Vernon Clinical Research; 🇺🇸 Sandy Springs, Georgia, United States

Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease; 🇺🇸 New Orleans, Louisiana, United States

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States

New England Center for Clinical Research; 🇺🇸 Fall River, Massachusetts, United States

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology; 🇺🇸 Cincinnati, Ohio, United States

Planned Parenthood Southeastern Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

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