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

Infection Clinical Trial

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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02386514
Study type Observational
Source Henry Ford Health System
Contact
Status Completed
Phase N/A
Start date June 2016
Completion date June 2016
View Details
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