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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02386514
Other study ID # 9107
Secondary ID
Status Completed
Phase N/A
First received January 9, 2015
Last updated January 2, 2017
Start date June 2016
Est. completion date June 2016

Study information

Verified date January 2017
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Henry Ford Hospital Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Henry Ford Health System Cepheid

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae comparative test characteristics to traditional swab in the Emergency Department. 24 hours No
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