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

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

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

Study Overview

• Status: Completed
• Conditions: Gonorrhea; Chlamydia Infections
• Intervention / Treatment: Device: APTIMA Assays; PANTHER System

• Study Type: Observational
• Enrollment (Actual): 1492

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90069
      • Anthony Mills MD Inc.
    • San Francisco, California, United States, 94102
      • Benchmark Research
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Planned Parenthood Southern New England
  • Florida
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trials
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Wishard Health Services
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • John Hopkins University
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02744
      • New England Center for Clinical Research - New Bedford Clinic
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Laboratory Corporation of America
    • Chapel Hill, North Carolina, United States, 27599-7030
      • University of North Carolina Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center
  • Tennessee
    • Maryville, Tennessee, United States, 37804
      • Molecular Pathology Laboratory Network, Inc.
  • Texas
    • Houston, Texas, United States, 77023
      • Planned Parenthood Houston and Southeast Texas
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research, Inc. -Tidewater Physicians for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Symptomatic and asymptomatic subjects at least 16 years of age.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Specimen Collection	Device: APTIMA Assays; PANTHER System; APTIMA Assays; PANTHER System; Other Names: APTIMA Combo, APTIMA CT, APTIMA GC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Gen-Probe, Incorporated

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 29, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 12, 2012

Study Record Updates

• Last Update Posted (Estimate): October 17, 2013
• Last Update Submitted That Met QC Criteria: October 16, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections; Gonorrhea
• Other Study ID Numbers: AGCPS-US11-002; AC2PS-US12-001 (Other Identifier: Gen-ProbeAC2PS-US12-001Eval of COMBO2 Assay On PANTHER System in Male Urine is testing protocol for AGCPS-US11-002)