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Emergency Department, Rapid Assessment for Sexually Transmitted Infection

NCT ID: NCT02386514

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cepheid

INDUSTRY

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Joseph Miller, MD

Clinical Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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Wilson SP, Vohra T, Goldberg J, Price C, Calo S, Mahan M, Miller J. Reliable Rapid Assay for Gonorrhea and Chlamydia in the Emergency Department. J Emerg Med. 2017 Dec;53(6):890-895. doi: 10.1016/j.jemermed.2017.08.094. Epub 2017 Oct 23.

Reference Type DERIVED
PMID: 29074030 (View on PubMed)

Other Identifiers

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9107

Identifier Type: -

Identifier Source: org_study_id

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