Prospective Collection of Female and Male Specimens for PANTHER® System Testing

Completed

Conditions studied: Chlamydia Infections, Gonorrhea

In brief

The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System

Key facts

Study ID

NCT01638637

Run by

Gen-Probe, Incorporated

People needed

1492

Starts

2012-02-01

Expected to finish

2013-07-01

Last updated by the study team

2013-10-17

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had 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 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 (female) is asymptomatic and undergoing a routine examination with a pelvic examination

You may not qualify if…

• A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Anthony Mills MD Inc. — Los Angeles, California, United States
• Benchmark Research — San Francisco, California, United States
• Planned Parenthood Southern New England — New Haven, Connecticut, United States
• AGA Clinical Trials — Hialeah, Florida, United States
• Wishard Health Services — Indianapolis, Indiana, United States
• Louisiana State University Health Sciences — New Orleans, Louisiana, United States
• John Hopkins University — Baltimore, Maryland, United States
• New England Center for Clinical Research - New Bedford Clinic — New Bedford, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Laboratory Corporation of America — Burlington, North Carolina, United States
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Molecular Pathology Laboratory Network, Inc. — Maryville, Tennessee, United States
• Planned Parenthood Houston and Southeast Texas — Houston, Texas, United States
• Tidewater Clinical Research, Inc. -Tidewater Physicians for Women — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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