Respiratory Tract Infection AcuteRadicalNCT03192072
A Rapid Test for Acute Respiratory Illness
An observational study of Respiratory Tract Infection Acute and Transcriptome, run by Duke University at 10 sites in United States.
Trial summary
The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard. Secondary objectives include: 1. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Respiratory Tract Infection Acute, Transcriptome, Virus Disease
- What is being tested?
- Host Gene Expression
- How many people
- 783 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Jul 2017to 19 Dec 2019
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 750 subjects may be enrolled at a minimum of 3 study sites from geographically diverse locations across the US. Subjects will be approached based on symptoms upon presentation to the health care facility's ED. In addition to these subjects, data from 450 previously enrolled subjects will be used. All demographic groups will have access to enrollment because anyone with acute respiratory infection (ARI) will be approached. Foreign language speaking subjects may be enrolled following review and approval of the appropriate consent process and documents by the reviewing IRB.
Who may be able to join
- Age 24 months or older
- Acute respiratory illness of less than 28 days in duration.
- Acute respiratory illness will be defined by at least two qualifying symptoms OR one qualifying symptom and at least 1 qualifying vital sign abnormality:
- Qualifying symptoms:Headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing
- Qualifying Vital Signs: Age greater than or equal to 2 and less than 6:Tachycardia (HR greater than or equal to 110), Tachynpnea (RR greater than or equal to 20),Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. Age greater than or equal to 6: Tachycardia(HR greater than or equal to 90), Tachynpnea (RR greater than or equal to 20), Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius.
- Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required.
Who cannot join
- Known or suspected infection at any other anatomic site requiring antibacterial therapy.
- Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
The University of California- Davis
Davis, California, 95616
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
The University of Texas- Houston
Houston, Texas, 77030
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Rhode Island/Lifespan
Providence, Rhode Island, 02903
University of Utah Medical Center
Salt Lake City, Utah, 84132
About this study
Official title: Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness
The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.
Secondary objectives include:
- Evaluate the effect of age on the performance of the HR-ARI test
- Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
- Evaluate the effect of geography on the performance of the HR-ARI test
Read the detailed description
The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.
Secondary objectives include:
- Evaluate the effect of age on the performance of the HR-ARI test
- Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
- Evaluate the effect of geography on the performance of the HR-ARI test
Subjects will be identified in the Emergency Department of participating hospitals. Samples including nasopharyngeal swab, throat swab, blood, and urine will be obtained.
A case report form for each subject will be completed to include information regarding clinical characteristics, signs and symptoms of infection, presence of complications, and patient outcome. Baseline characteristics including preexisting conditions. Survival data will also be collected for each subject.
Samples collected will be used to characterize the patient's illness as either infectious or not, and if infectious, either bacterial or viral. Samples will also be used to measure changes in gene expression, referred to as the Host Response-Acute Respiratory Illness (HR-ARI) test.
The result of this test will be made in comparison to a retrospective review of the subject's clinical information. Results will not be used for any interventions and will not be released to subjects or their providers.
Because the study procedure includes only sample and data collection, the risks will be minimal and no different than encountered during routine clinical care.
The study was re-assessed in 2020 and applicable updates were made to the record.
- Being tested
- Host Gene Expression
- Medical subject headings
- Virus Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Host Gene ExpressionDiagnostic test
Also called Adjudication
comparison to retrospective clinical adjudication
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Acute Respiratory Illness | Patients with acute respiratory illness identified in the Emergency Department Receives: Diagnostic Test: Host Gene Expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value with reference standard (PPV)
Number of assay positives that agree with the reference standard / [Number of assay positives that agree with the reference standard + Number of assay positives that disagree with the reference standard]
Measured: Day 1
Negative predictive value with the reference standard (NPV)
Number of assay negatives that agree with the reference standard / [number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard]
Measured: Day 1
Secondary outcomes (1)
Overall agreement with the reference standard (OA)
Number of samples that agree with the reference standard / all samples tested
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start17 Jul 2017
- Primary completion6 Sep 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Infection AcuteStudies of the same condition, open and under way.
- More trials run by Duke 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 783 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Antibacterial Resistance Leadership Group
- Responsible party
- Sponsor
- Investigators
- Christopher Woods, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192072
- Sponsor's protocol ID
- Pro00082317
- Other IDs
- Pro00082322
- Acronym
- Radical
- Status last verified
- May 2020
- First submitted
- 16 Jun 2017
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness
- ClinicalTrials.gov ID
- NCT03192072
- Acronym / sponsor ID
- Radical / Pro00082317
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Antibacterial Resistance Leadership Group
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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 primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.
Secondary objectives include:
- Evaluate the effect of age on the performance of the HR-ARI test
- Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
- Evaluate the effect of geography on the performance of the HR-ARI test
Detailed description
The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.
Secondary objectives include:
- Evaluate the effect of age on the performance of the HR-ARI test
- Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
- Evaluate the effect of geography on the performance of the HR-ARI test
Subjects will be identified in the Emergency Department of participating hospitals. Samples including nasopharyngeal swab, throat swab, blood, and urine will be obtained.
A case report form for each subject will be completed to include information regarding clinical characteristics, signs and symptoms of infection, presence of complications, and patient outcome. Baseline characteristics including preexisting conditions. Survival data will also be collected for each subject.
Samples collected will be used to characterize the patient's illness as either infectious or not, and if infectious, either bacterial or viral. Samples will also be used to measure changes in gene expression, referred to as the Host Response-Acute Respiratory Illness (HR-ARI) test.
The result of this test will be made in comparison to a retrospective review of the subject's clinical information. Results will not be used for any interventions and will not be released to subjects or their providers.
Because the study procedure includes only sample and data collection, the risks will be minimal and no different than encountered during routine clinical care.
The study was re-assessed in 2020 and applicable updates were made to the record.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Acute Respiratory Illness | – | Diagnostic Test: Host Gene ExpressionPatients with acute respiratory illness identified in the Emergency Department |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 750 subjects may be enrolled at a minimum of 3 study sites from geographically diverse locations across the US. Subjects will be approached based on symptoms upon presentation to the health care facility's ED. In addition to these subjects, data from 450 previously enrolled subjects will be used. All demographic groups will have access to enrollment because anyone with acute respiratory infection (ARI) will be approached. Foreign language speaking subjects may be enrolled following review and approval of the appropriate consent process and documents by the reviewing IRB.
Key inclusion criteria (6 listed)
- Age 24 months or older
- Acute respiratory illness of less than 28 days in duration.
- Acute respiratory illness will be defined by at least two qualifying symptoms OR one qualifying symptom and at least 1 qualifying vital sign abnormality:
- Qualifying symptoms:Headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing
- Qualifying Vital Signs: Age greater than or equal to 2 and less than 6:Tachycardia (HR greater than or equal to 110), Tachynpnea (RR greater than or equal to 20),Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. Age greater than or equal to 6: Tachycardia(HR greater than or equal to 90), Tachynpnea (RR greater than or equal to 20), Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius.
Key exclusion criteria (2 listed)
- Known or suspected infection at any other anatomic site requiring antibacterial therapy.
- Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial.
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 |
|---|---|---|
| Host Gene ExpressionAlso: Adjudicationcomparison to retrospective clinical adjudication | Diagnostic test | Subjects with Acute Respiratory Illness |
Primary outcome
Positive predictive value with reference standard (PPV)
Time frame: Day 1
Number of assay positives that agree with the reference standard / [Number of assay positives that agree with the reference standard + Number of assay positives that disagree with the reference standard]
Negative predictive value with the reference standard (NPV)
Time frame: Day 1
Number of assay negatives that agree with the reference standard / [number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard]
1 secondary outcome
Overall agreement with the reference standard (OA)
Time frame: Day 1
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 27 May 2020.
- Individual participant dataSharing planned: No
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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.
Christopher Woods, MD, MPH principal investigator
Duke University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infection Acute and Transcriptome, run by Duke University at 10 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 6 inclusion and 2 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Positive predictive value with reference standard (PPV) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2020.