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

Gonorrhea Clinical Trial

Official title:

Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01728103
• Other study ID #: ATVTS-US12-001
• Secondary ID: AC2PS-US12-002AT
• Status: Terminated
• Phase: N/A
• First received: November 12, 2012
• Last updated: August 14, 2017
• Start date: January 2013

Study information

• Verified date: August 2017
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1336
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia Infections
• Communicable Diseases
• Gonorrhea
• Infection
• Trichomonas Infections

Intervention

Device:
• APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
In Vitro Diagnostic Assays

Locations

Country	Name	City	State
United States	John Hopkins University	Baltimore	Maryland
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	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology	Cincinnati	Ohio
United States	New England Center for Clinical Research	Fall River	Massachusetts
United States	Planned Parenthood Gulf Coast	Houston	Texas
United States	The Jackson Clinic	Jackson	Tennessee
United States	Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease	New Orleans	Louisiana
United States	Tidewater Clinical Research	Norfolk	Virginia
United States	Healthcare Clinical Data	North Miami	Florida
United States	Planned Parenthood Southeastern Pennsylvania	Philadelphia	Pennsylvania
United States	Medical Center for Clinical Research	San Diego	California
United States	Mount Vernon Clinical Research	Sandy Springs	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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