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

Gonorrhea Clinical Trial

Official title:

Prospective Collection of Female First-catch Urine, Vaginal Swab, Cervical, and Endocervical Swab Specimens and Male Urethral Swab and First-catch Urine Specimens for Testing With the PANTHER® System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638637
• Other study ID #: AGCPS-US11-002
• Secondary ID: AC2PS-US12-001
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: October 16, 2013
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1492
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chlamydia Infections
• Gonorrhea

Intervention

Device:
• APTIMA Assays; PANTHER System
APTIMA Assays; PANTHER System

Locations

Country	Name	City	State
United States	John Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
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	AGA Clinical Trials	Hialeah	Florida
United States	Planned Parenthood Houston and Southeast Texas	Houston	Texas
United States	Wishard Health Services	Indianapolis	Indiana
United States	Anthony Mills MD Inc.	Los Angeles	California
United States	Molecular Pathology Laboratory Network, Inc.	Maryville	Tennessee
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	New England Center for Clinical Research - New Bedford Clinic	New Bedford	Massachusetts
United States	Planned Parenthood Southern New England	New Haven	Connecticut
United States	Louisiana State University Health Sciences	New Orleans	Louisiana
United States	Tidewater Clinical Research, Inc. -Tidewater Physicians for Women	Norfolk	Virginia
United States	Benchmark Research	San Francisco	California

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 (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease		approximately one year	No