Emergency Department, Rapid Assessment for Sexually Transmitted Infection

Infection Clinical Trial

— ED-RASTI  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386514
• Other study ID #: 9107
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Sexually Transmitted Diseases

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