此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

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

2013年3月8日更新者：Gen-Probe, Incorporated

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.

研究概览

地位

撤销

条件

沙眼衣原体

干预/治疗

设备：APTIMA Assay for Chlamydia trachomatis

详细说明

This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis)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

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Indiana
  - Indianapolis、Indiana、美国、46202
    - Wishard Health Services Department of Pathology Wishard Health Services
- Louisiana
  - New Orleans、Louisiana、美国、92122
    - Louisianna State University Health Center
- Massachusetts
  - Fall River、Massachusetts、美国、02720
    - New England Center for Clinical Research
- North Carolina
  - Chapel Hill、North Carolina、美国、27599
    - University of North Carolina Chapel Hill STD Clinic
- Ohio
  - Akron、Ohio、美国、44302
    - Planned Parenthood Northeast Ohio
  - Cincinnati、Ohio、美国、45229
    - Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
- Texas
  - Houston、Texas、美国、77023
    - Planned Parenthood Houston and Southeast Texas

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年及以上 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference 大体时间：approximately one year	Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference	approximately one year

次要结果测量

结果测量	措施说明	大体时间
阳性率大体时间：大约一年	阳性率	大约一年

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gen-Probe, Incorporated

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年11月1日

初级完成 (实际的)

2012年1月1日

研究完成 (实际的)

2012年1月1日

研究注册日期

首次提交

2011年5月20日

首先提交符合 QC 标准的

2011年5月23日

首次发布 (估计)

2011年5月24日

研究记录更新

最后更新发布 (估计)

2013年3月12日

上次提交的符合 QC 标准的更新

2013年3月8日

最后验证

2013年3月1日