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Emergency Department, Rapid Assessment for Sexually Transmitted Infection (ED-RASTI)

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ClinicalTrials.gov Identifier: NCT02386514
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : January 4, 2017
Sponsor:
Collaborator:
Cepheid
Information provided by (Responsible Party):
Joseph Miller, MD, Henry Ford Health System

Brief Summary:
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.

Condition or disease
Infection

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
Actual Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea




Primary Outcome Measures :
  1. Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae [ Time Frame: 24 hours ]
    comparative test characteristics to traditional swab in the Emergency Department.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

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): NCT02386514


Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Cepheid

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Miller, MD, Clinical Physician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02386514     History of Changes
Other Study ID Numbers: 9107
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by Joseph Miller, MD, Henry Ford Health System:
sexually transmitted infection
gonorrhea
chlamydia
presumptive therapy

Additional relevant MeSH terms:
Infection
Communicable Diseases
Sexually Transmitted Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female