InfectionED-RASTINCT02386514
Emergency Department, Rapid Assessment for Sexually Transmitted Infection
An observational study of Infection, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients greater than 18 years of age presenting with a complaint that triggers the providing clinician to obtain a gonorrhea and chlamydia test by the traditional format.
Who may be able to join
- Clinical concern for gonorrhea and/or chlamydia infection
- Concurrent testing for gonorrhea and chlamydia using traditional NAAT assay
Who cannot join
- age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infection
- Keywords
- sexually transmitted infection, gonorrhea, chlamydia, presumptive therapy
- Medical subject headings
- Infections, Sexually Transmitted Diseases, Gonorrhea, Chlamydia Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae
comparative test characteristics to traditional swab in the Emergency Department.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid
- Responsible party
- Principal investigator, Joseph Miller, MD, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386514
- Sponsor's protocol ID
- 9107
- Acronym
- ED-RASTI
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29074030
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department, Rapid Assessment for Sexually Transmitted Infection
- ClinicalTrials.gov ID
- NCT02386514
- Acronym / sponsor ID
- ED-RASTI / 9107
- Conditions
- Infection
- Keywords
- sexually transmitted infection, gonorrhea, chlamydia, presumptive therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Cepheid
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients greater than 18 years of age presenting with a complaint that triggers the providing clinician to obtain a gonorrhea and chlamydia test by the traditional format.
Key inclusion criteria (2 listed)
- Clinical concern for gonorrhea and/or chlamydia infection
- Concurrent testing for gonorrhea and chlamydia using traditional NAAT assay
Key exclusion criteria (1 listed)
- age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae
Time frame: 24 hours
comparative test characteristics to traditional swab in the Emergency Department.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Derived from this study: PubMed 29074030Wilson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.