- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02386514
Emergency Department, Rapid Assessment for Sexually Transmitted Infection (ED-RASTI)
January 2, 2017 updated by: Joseph Miller, MD, Henry Ford Health System
To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to the traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency Department.
Study Overview
Status
Completed
Conditions
Detailed Description
All patients presenting to the Emergency Department during the study period who are tested for gonorrhea and chlamydia by the traditional swab NAAT will concurrently have their urine tested for gonorrhea and chlamydia using the Cepheid GeneXpert rapid NAAT.
The result of both tests will be compared to determine if the rapid assay is non-inferior to the current traditional NAAT.
Both the traditional and Cepheid GeneXpert rapid NAAT are FDA and CDC approved for evaluation of gonorrhea and chlamydia.
However, the Cepheid GeneXpert rapid NAAT has not been prospectively validated in the Emergency Department setting.
We intend for both the provider obtaining the sample and the technician running the rapid assay sample to be blinded to the result of the traditional NAAT.
The Cepheid GeneXpert rapid NAAT will not be used in patient care decisions.
Study Type
Observational
Enrollment (Actual)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients greater than 18 years of age presenting with a complaint that triggers the providing clinician to obtain a gonorrhea and chlamydia test by the traditional format.
Description
Inclusion Criteria:
- Clinical concern for gonorrhea and/or chlamydia infection
- Concurrent testing for gonorrhea and chlamydia using traditional NAAT assay
Exclusion Criteria:
- age <18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae
Time Frame: 24 hours
|
comparative test characteristics to traditional swab in the Emergency Department.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
January 9, 2015
First Submitted That Met QC Criteria
March 6, 2015
First Posted (Estimate)
March 12, 2015
Study Record Updates
Last Update Posted (Estimate)
January 4, 2017
Last Update Submitted That Met QC Criteria
January 2, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9107 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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