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Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System

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ClinicalTrials.gov Identifier: NCT01358799
Recruitment Status : Withdrawn (Assay not evaluated for purpose of clearance)
First Posted : May 24, 2011
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated

Brief Summary:
The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Condition or disease Intervention/treatment
Chlamydia Trachomatis Device: APTIMA Assay for Chlamydia trachomatis

Detailed Description:
This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis) Assay. Instead, testing was conducted and results were generated with the Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended by the RRS team per their email to me on 8 February 2013.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
Study Start Date : November 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: APTIMA Assay for Chlamydia trachomatis
    APTIMA Assay for Chlamydia trachomatis
    Other Name: Chlamydia trachomatis


Primary Outcome Measures :
  1. Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference [ Time Frame: approximately one year ]
    Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference


Secondary Outcome Measures :
  1. Positivity Rate [ Time Frame: approximately one year ]
    Positivity Rate


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.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 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 IRBapproved 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358799


Locations
United States, Indiana
Wishard Health Services Department of Pathology Wishard Health Services
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisianna State University Health Center
New Orleans, Louisiana, United States, 92122
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

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01358799     History of Changes
Other Study ID Numbers: ACTPS-US10-001
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Gen-Probe, Incorporated:
Chlamydia trachomatis
APTIMA Assay for Chlamydia trachomatis

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