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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01638637
First received: February 29, 2012
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Chlamydia Infections
Gonorrhea
Device: APTIMA Assays; PANTHER System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Gen-Probe, Incorporated:

Primary Outcome Measures:
  • 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 [ Time Frame: approximately one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

urine


Enrollment: 1492
Study Start Date: February 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Specimen Collection Device: APTIMA Assays; PANTHER System
APTIMA Assays; PANTHER System
Other Name: APTIMA Combo, APTIMA CT, APTIMA GC

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Symptomatic and asymptomatic subjects at least 16 years of age.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638637

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

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01638637     History of Changes
Other Study ID Numbers: AGCPS-US11-002, AC2PS-US12-001
Study First Received: February 29, 2012
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections

ClinicalTrials.gov processed this record on August 20, 2014