Emergency Department, Rapid Assessment for Sexually Transmitted Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02386514

Acronym

ED-RASTI

Enrollment

1200

Registered

2015-03-12

Start date

2016-06-30

Completion date

2016-06-30

Last updated

2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

sexually transmitted infection, gonorrhea, chlamydia, presumptive therapy

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae	24 hours	comparative test characteristics to traditional swab in the Emergency Department.

Countries

United States

Outcome results