InfluenzaNCT01947049
Influenza Diagnosis, Treatment and Surveillance With Xpert Flu
A study testing Rapid Influenza Testing with Xpert Flu in people with Influenza, run by Johns Hopkins University at 4 sites in United States.
Trial summary
The purpose of this study is to: 1. Evaluate the clinical performance of a newly available highly-sensitive rapid influenza test, Xpert Flu. 2. Derive and validate an adult clinical decision guideline to guide clinical testing of influenza patients who meed CDC criteria for antiviral treatment. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Rapid Influenza Testing with Xpert Flu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,011 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2013to 30 Jun 2014
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Acute respiratory tract infection, i.e. in the past two days the subject has experienced any of the following symptoms: new or increased cough, new or increased shortness of breath, change in sputum production (for adults 65 years or older), new sinus pain, new nasal congestion/rhinorrhea, new sore throat, new fever, triage temperature greater than or equal to 38F
- CDC Criteria for influenza antiviral treatment, i.e. is the subject at risk for influenza complications or does the subject have potential current influenza complications including: 65 years old or older, pregnant (or less than 2 weeks post-partum), American Indian or Alaska Native, morbid obesity (BMI greater than 40), current resident of a chronic care facility, chronic pulmonary disease, cardiovascular disease (except isolated hypertension), renal disease, hepatic disease, hematologic disease, metabolic disease, neurologic disease, immunosupression due to [HIV or AIDS, transplant, chemotherapy, medications, other - specify]. OR does the subject have potential current influenza complications such as: admitted to the hospital or a diagnosis of pneumonia.
Who cannot join
- Unable to speak or understand English or Spanish
- Unable to provide consent
- Lack of follow up information (i.e. working telephone number)
- Have an influenza diagnosis in the past 2 weeks (i.e. either given antivirals or had a confirmatory influenza test)
- Previously enrolled in this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Truman Medical Center
Kansas City, Missouri, 64108
Maricopa Medical Center
Phoenix, Arizona, 85008
Olive View - UCLA Medical Center
Sylmar, California, 91342
About this study
The purpose of this study is to:
- Evaluate the clinical performance of a newly available highly-sensitive rapid influenza test, Xpert Flu.
- Derive and validate an adult clinical decision guideline to guide clinical testing of influenza patients who meed CDC criteria for antiviral treatment.
- Evaluate impact of rapid influenza testing for antiviral treatment.
- Determine cost effectiveness of influenza testing and treatment strategies.
Read the detailed description
Four strategically selected medical centers across the US (representing the West Coast, Southwest, Midwest; and East Coast) will enroll adult subjects presenting to the ED with an acute respiratory illness who fulfill CDC recommended criteria for receiving antiviral therapy. At each of the 4 sites, dedicated research coordinators will approach all adult (age > 18 years old) ED patients with broadly defined respiratory related complaints and screen for those who meet CDC recommended criteria for antiviral therapy (i.e. those at 'high-risk for complications' or those with 'potential influenza-related complications).
Consenting subjects will have a nasopharyngeal (NP) swab collected for both Xpert Flu testing and gold standard reverse transcription-PCR (rt-PCR) testing under a research protocol. The investigators will compare the test results from the rapid flu testing to that of the gold standard rt-PCR testing in order to assess the clinical performance characteristics of the new rapid test (Objective 1). The investigators will also collect demographics and medical historical information using a brief structured data form, which will be used in combination with rt-PCR test results to derive and validate a clinical decision guideline (Objective 2).
The investigators will simultaneously randomize 2 of the 4 hospitals to the Rapid Testing Group (which will have systematic rapid flu testing performed with results provided to the clinicians), or the Control Group (which will follow standard of care practice with testing left to the discretion of individual clinicians). This will permit comparison of rates of ED antiviral administration or prescription between the two groups to assess the clinical impact of influenza testing (Objective 3). Finally, cost data from the ED visits and subsequent hospitalization will be collected from subjects in both the rapid testing group and the control group to inform a cost-utility analysis of rapid influenza testing compared to current standard of care (Objective 4).
- Conditions
- Influenza
- Being tested
- Rapid Influenza Testing with Xpert Flu
- Keywords
- Influenza, diagnostic testing, antiviral treatment, rapid influenza testing
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Influenza Testing with Xpert FluOther
Participants with recieve rapid influenza testing with Xpert Flu
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Participants in this arm will receive usual care (influenza testing and treatment) |
| Rapid Testing | Experimental | Participants in this arm will receive rapid influenza testing with Xpert Flu. Receives: Other: Rapid Influenza Testing with Xpert Flu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of Xpert Flu
The primary outcome is the sensitivity and specificity of Cepheid Xpert Flu in detecting Influenza, as well as the positive and negative predictive value.
Measured: one year
Secondary outcomes (3)
Clinical decision guideline
Using rt-PCR as the gold standard for influenza testing, we will initially evaluate signs and symptoms (such as cough, fever, sore throat, shortness of breath, etc.) for their sensitivity, specificity and likelihood ratio for diagnosing influenza.
Measured: one year
Clinical Utility of Xpert Flu
Clinical utility is defined here as the proportion of high-risk subjects with confirmed influenza receiving antiviral or antiviral prescriptions in the ED in the Rapid Testing Group compared to the Control Group.
Measured: one year
Cost-effectiveness
We will perform a cost-utility analysis from the societal perspective comparing the following 4 treatment strategies: 1) treat all; 2) treat none; 3) treat based on clinical judgment; 4) treat based on Xpert Flu.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJul 2013
- Primary completion30 Jun 2014
- Study completion30 Jun 2014
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 InfluenzaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Rich Rothman, Johns Hopkins University
- Investigators
- Andrea Dugas, MD, Principal investigator, Johns Hopkins UniversityRichard Rothman, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947049
- Sponsor's protocol ID
- 6 IDSEP130014-01-01
- Status last verified
- Sep 2017
- First submitted
- 17 Sep 2013
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dugas AF, Hsieh YH, LoVecchio F, Moran GJ, Steele MT, Talan DA, Rothman RE; Emergency Department National Influenza Network Investigators. Derivation and Validation of a Clinical Decision Guideline for Influenza Testing in 4 US Emergency Departments. Clin Infect Dis. 2020 Jan 1;70(1):49-58. doi: 10.1093/cid/ciz171.
PubMed 30843056
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Diagnosis, Treatment and Surveillance With Xpert Flu
- ClinicalTrials.gov ID
- NCT01947049
- Acronym / sponsor ID
- 6 IDSEP130014-01-01
- Conditions
- Influenza
- Keywords
- Influenza, diagnostic testing, antiviral treatment, rapid influenza testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,011 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Jul 2013
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 20 Sep 2013 (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.
The purpose of this study is to:
- Evaluate the clinical performance of a newly available highly-sensitive rapid influenza test, Xpert Flu.
- Derive and validate an adult clinical decision guideline to guide clinical testing of influenza patients who meed CDC criteria for antiviral treatment.
- Evaluate impact of rapid influenza testing for antiviral treatment.
- Determine cost effectiveness of influenza testing and treatment strategies.
Detailed description
Four strategically selected medical centers across the US (representing the West Coast, Southwest, Midwest; and East Coast) will enroll adult subjects presenting to the ED with an acute respiratory illness who fulfill CDC recommended criteria for receiving antiviral therapy. At each of the 4 sites, dedicated research coordinators will approach all adult (age > 18 years old) ED patients with broadly defined respiratory related complaints and screen for those who meet CDC recommended criteria for antiviral therapy (i.e. those at 'high-risk for complications' or those with 'potential influenza-related complications).
Consenting subjects will have a nasopharyngeal (NP) swab collected for both Xpert Flu testing and gold standard reverse transcription-PCR (rt-PCR) testing under a research protocol. The investigators will compare the test results from the rapid flu testing to that of the gold standard rt-PCR testing in order to assess the clinical performance characteristics of the new rapid test (Objective 1). The investigators will also collect demographics and medical historical information using a brief structured data form, which will be used in combination with rt-PCR test results to derive and validate a clinical decision guideline (Objective 2).
The investigators will simultaneously randomize 2 of the 4 hospitals to the Rapid Testing Group (which will have systematic rapid flu testing performed with results provided to the clinicians), or the Control Group (which will follow standard of care practice with testing left to the discretion of individual clinicians). This will permit comparison of rates of ED antiviral administration or prescription between the two groups to assess the clinical impact of influenza testing (Objective 3). Finally, cost data from the ED visits and subsequent hospitalization will be collected from subjects in both the rapid testing group and the control group to inform a cost-utility analysis of rapid influenza testing compared to current standard of care (Objective 4).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Participants in this arm will receive usual care (influenza testing and treatment) |
| Rapid Testing | Experimental | Other: Rapid Influenza Testing with Xpert FluParticipants in this arm will receive rapid influenza testing with Xpert Flu. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older
- Acute respiratory tract infection, i.e. in the past two days the subject has experienced any of the following symptoms: new or increased cough, new or increased shortness of breath, change in sputum production (for adults 65 years or older), new sinus pain, new nasal congestion/rhinorrhea, new sore throat, new fever, triage temperature greater than or equal to 38F
- CDC Criteria for influenza antiviral treatment, i.e. is the subject at risk for influenza complications or does the subject have potential current influenza complications including: 65 years old or older, pregnant (or less than 2 weeks post-partum), American Indian or Alaska Native, morbid obesity (BMI greater than 40), current resident of a chronic care facility, chronic pulmonary disease, cardiovascular disease (except isolated hypertension), renal disease, hepatic disease, hematologic disease, metabolic disease, neurologic disease, immunosupression due to [HIV or AIDS, transplant, chemotherapy, medications, other - specify]. OR does the subject have potential current influenza complications such as: admitted to the hospital or a diagnosis of pneumonia.
Key exclusion criteria (5 listed)
- Unable to speak or understand English or Spanish
- Unable to provide consent
- Lack of follow up information (i.e. working telephone number)
- Have an influenza diagnosis in the past 2 weeks (i.e. either given antivirals or had a confirmatory influenza test)
- Previously enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Influenza Testing with Xpert FluParticipants with recieve rapid influenza testing with Xpert Flu | Other | Rapid Testing |
Primary outcome
Clinical performance of Xpert Flu
Time frame: one year
The primary outcome is the sensitivity and specificity of Cepheid Xpert Flu in detecting Influenza, as well as the positive and negative predictive value.
3 secondary outcomes
Clinical decision guideline
Time frame: one year
Clinical Utility of Xpert Flu
Time frame: one year
Cost-effectiveness
Time frame: one year
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 18 Sep 2017.
- Derived from this study: PubMed 30843056Dugas AF, Hsieh YH, LoVecchio F, Moran GJ, Steele MT, Talan DA, Rothman RE; Emergency Department National Influenza Network Investigators. Derivation and Validation of a Clinical Decision Guideline for Influenza Testing in 4 US Emergency Departments. Clin Infect Dis. 2020 Jan 1;70(1):49-58. doi: 10.1093/cid/ciz171.
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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.
Andrea Dugas, MD principal investigator
Johns Hopkins University
Richard Rothman, MD, PhD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Influenza Testing with Xpert Flu in people with Influenza, run by Johns Hopkins University at 4 sites 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 3 inclusion and 5 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Clinical performance of Xpert Flu (time frame: one year). 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 NCT01947049, 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 18 Sep 2017.