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



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:11/8/2014
Start Date:January 2013
End Date:September 2014
Contact:Patty Law, MS
Email:patty.law@hologic.com
Phone:858-731-5919

Use our guide to learn which trials are right for you!

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

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.


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
We found this trial at
14
sites
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
1101 East 33rd Street
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
Houston, Texas 77023
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jackson, Tennessee 38301
?
mi
from
Jackson, TN
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
North Miami, Florida 33161
?
mi
from
North Miami, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
San Diego, California 92108
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sandy Springs, Georgia 30328
?
mi
from
Sandy Springs, GA
Click here to add this to my saved trials