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Trial record 1 of 1 for:    NCT03192072
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A Rapid Test for Acute Respiratory Illness (Radical)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192072
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Antibacterial Resistance Leadership Group
Information provided by (Responsible Party):
Duke University

Brief 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. Evaluate the effect of age on the performance of the HR-ARI test
  2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
  3. Evaluate the effect of geography on the performance of the HR-ARI test

Condition or disease Intervention/treatment
Respiratory Tract Infection Acute Transcriptome Virus Disease Bacterial Infections Diagnostic Test: Host Gene Expression

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:

  1. Evaluate the effect of age on the performance of the HR-ARI test
  2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
  3. 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.

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Study Type : Observational
Actual Enrollment : 783 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness
Actual Study Start Date : July 17, 2017
Actual Primary Completion Date : September 6, 2019
Actual Study Completion Date : December 19, 2019

Group/Cohort Intervention/treatment
Subjects with Acute Respiratory Illness
Patients with acute respiratory illness identified in the Emergency Department
Diagnostic Test: Host Gene Expression
comparison to retrospective clinical adjudication
Other Name: Adjudication




Primary Outcome Measures :
  1. 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]

  2. 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]


Secondary Outcome Measures :
  1. Overall agreement with the reference standard (OA) [ Time Frame: Day 1 ]
    Number of samples that agree with the reference standard / all samples tested


Biospecimen Retention:   Samples With DNA
Samples will include blood, urine, nasopharyngeal and throat swabs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

A. Age 24 months or older

B. Acute respiratory illness of less than 28 days in duration.

C. 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.

D. Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required.

Exclusion Criteria:

A. Known or suspected infection at any other anatomic site requiring antibacterial therapy.

B. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192072


Locations
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United States, California
The University of California- Davis
Davis, California, United States, 95616
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island/Lifespan
Providence, Rhode Island, United States, 02903
United States, Texas
The University of Texas- Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Duke University
Antibacterial Resistance Leadership Group
Investigators
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Principal Investigator: Christopher Woods, MD, MPH Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03192072    
Other Study ID Numbers: Pro00082317
Pro00082322 ( Other Identifier: Duke UMC )
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Bacterial Infections
Virus Diseases
Respiratory Tract Diseases