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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
Health authority
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. completion date
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

Study Design


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
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