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Completed

NCT Number: NCT02386514

Emergency Department, Rapid Assessment for Sexually Transmitted Infection

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.

Completed

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Key information

Conditions

Infection Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Disease Attributes Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae

    Time frame: 24 hours

    comparative test characteristics to traditional swab in the Emergency Department.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Cepheid

Registry information

Acronym: ED-RASTI

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2015
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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