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

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ClinicalTrials.gov Identifier: NCT01733069
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : April 24, 2013
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated

Tracking Information
First Submitted Date November 20, 2012
First Posted Date November 26, 2012
Results First Submitted Date March 7, 2013
Results First Posted Date April 24, 2013
Last Update Posted Date January 14, 2014
Study Start Date November 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2013)
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type [ Time Frame: Baseline ]
Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
Original Primary Outcome Measures
 (submitted: November 20, 2012)
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference [ Time Frame: approximately 1 year ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
Official Title Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System
Brief Summary 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.
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The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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
Sampling Method Probability Sample
Study Population Male and Females at least 14 years of age at the time of informed consent and sexually active.
Condition
  • Chlamydia Trachomatis
  • Neisseria Gonorrhoeae Infection
Intervention Device: APTIMA COMBO 2 Assay (AC2 Assay)
APTIMA COMBO 2 Assay (AC2 Assay
Study Groups/Cohorts No treatment
Intervention: Device: APTIMA COMBO 2 Assay (AC2 Assay)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 26, 2013)
1912
Original Actual Enrollment
 (submitted: November 20, 2012)
1947
Actual Study Completion Date February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01733069
Other Study ID Numbers AC2PS-US11-001
ACTPS-US10-001 ( Other Identifier: Gen-Probe )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gen-Probe, Incorporated
Study Sponsor Gen-Probe, Incorporated
Collaborators Not Provided
Investigators
Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated
PRS Account Gen-Probe, Incorporated
Verification Date November 2013