Clinical trial NCT01358799: Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
Official title: Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chlamydia Trachomatis
Keywords: Chlamydia trachomatis
APTIMA Assay for Chlamydia trachomatis
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Male and Females at least 14 years of age at the time of informed consent and sexually active.

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.

Detailed description: This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis)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.

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 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.

Primary outcomes:
measure: Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference
timeFrame: approximately one year
Secondary outcomes:
measure: Positivity Rate
timeFrame: approximately one year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Wishard Health Services Department of Pathology Wishard Health Services
state: Indiana
city: New Orleans
country: United States
facility: Louisianna State University Health Center
state: Louisiana
city: Fall River
country: United States
facility: New England Center for Clinical Research
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill STD Clinic
state: North Carolina
city: Akron
country: United States
facility: Planned Parenthood Northeast Ohio
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
state: Ohio
city: Houston
country: United States
facility: Planned Parenthood Houston and Southeast Texas
state: Texas
Study officials:
affiliation: Gen-Probe, Incorporated
name: Jennifer Reid, PhD
role: STUDY_DIRECTOR
References: