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Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01733069
First received: November 20, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.


Condition Intervention
Chlamydia Trachomatis
Neisseria Gonorrhoeae Infection
Device: APTIMA COMBO 2 Assay (AC2 Assay)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System

Resource links provided by NLM:


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

Primary Outcome Measures:
  • APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)


Biospecimen Retention:   Samples With DNA

4 specimens will be collected from each female subject in the following order: 1 first-catch urine specimen, 1 vaginal swab specimen (patient or clinician-collected), 1 cervical specimen (using a broomlike collection device or a brush/spatula combination), and 1 endocervical swab specimen. An additional cervical specimen may be collected from female subjects for other clinical trial purposes or research studies. Up to 2 specimens will be collected from each male subject in the following order: 1 urethral swab specimen and 1 first-catch urine specimen


Enrollment: 1912
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment Device: APTIMA COMBO 2 Assay (AC2 Assay)
APTIMA COMBO 2 Assay (AC2 Assay

Detailed Description:

The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from protocol ACTPS-US10-001(NCT01358799).

The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Male and Females at least 14 years of age at the time of informed consent and sexually active.

Criteria

Inclusion Criteria:

•The subject is at least 14 years of age at the time of informed consent and is sexually active

  • The subject reports symptoms consistent with a suspected STD (sexually transmitted disease) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort.
  • If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam
  • 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 IRB (institutional review board) approved waiver for parental consent for minors)

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
  • The subject is underage (as defined by the IRB (institutional review board) or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors)
  • The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.
  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: NCT01733069

Locations
United States, Indiana
Wishard Health Services Department of Pathology Wishard Health Services
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana State University Health Center
New Orleans, Louisiana, United States, 70122
United States, Massachusetts
New England Center for Clinical Research
Fall River, Massachusetts, United States, 02720
United States, North Carolina
University of North Carolina Chapel Hill STD Clinic
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Planned Parenthood Northeast Ohio
Akron, Ohio, United States, 44302
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, United States, 45229
United States, Texas
Planned Parenthood Houston and Southeast Texas
Houston, Texas, United States, 77023
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: NCT01733069     History of Changes
Other Study ID Numbers: AC2PS-US11-001, ACTPS-US10-001
Study First Received: November 20, 2012
Results First Received: March 7, 2013
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014