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HostDx Sepsis in Patients With Acute Respiratory Infections

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: NCT03744741
Recruitment Status : Active, not recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
University of Kentucky
Texas Tech University
Information provided by (Responsible Party):
Inflammatix

Brief Summary:
This study will analyze gene expression data (HostDx Sepsis test) from blood samples collected from participants with suspected respiratory infections. The primary endpoint of the study is to prospectively validate the HostDx Sepsis test for infections. As a secondary endpoint the correlation of participant prognosis and gene expression results in the HostDx Sepsis test will be validated. Participants presenting to the emergency departments of enrolling sites with a suspected bacterial or viral respiratory infection and 2+ vital signs are meeting enrollment criteria

Condition or disease Intervention/treatment
Respiratory Tract Infections Diagnostic Test: HostDx Sepsis

Detailed Description:

Enrollment will be offered to patients who meet criteria (defined below) at presentation to the emergency department. All patients will undergo standard-of-care treatment. Fig. 1 provides an overview of the study design.

Blood sample collections: Clinical study staff or the treating physician will obtain patient consent and collect two PAXgene RNA tubes of whole blood by venipuncture. The blood samples will be stored at room temperature overnight prior to being frozen at -80C for long-term storage. Samples will be shipped to the sponsor for testing using the HostDX Sepsis test. An additional tube of blood obtained via venipuncture and stored for shipment to a centralized testing laboratory, where it will be tested for C-reactive protein (CRP) and procalcitonin (PCT). This will be done for all participants, even if they had these tests ordered locally as standard of care (SOC).

Microbiology sample collections: For diagnosed/unhealthy participants (regardless whether they had or had not provided a nasopharyngeal swab for a respiratory panel), a nasopharyngeal swab for a respiratory pathogen panel will be obtained and sent to a central laboratory for testing.

For participants with a productive cough and if sputum culture is SOC at the clinical site, a sputum culture will be ordered and run in the local microbiology lab, Participants will receive the institution's standard of care treatment for respiratory infection.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Acute Respiratory Infections: a Multicenter Pilot Study
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis


Intervention Details:
  • Diagnostic Test: HostDx Sepsis
    Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection
    Other Names:
    • Procalcitonin
    • C-reactive protein
    • Molecular respiratory pathogen panel


Primary Outcome Measures :
  1. Concordance of HostDx Sepsis diagnostic test read-out: likelihood of bacterial infection [ Time Frame: 30 days after enrollment ]
    Percent agreement of HostDx Sepsis bacterial readout with clinical adjudication by physician 30 days after enrollment for the presence of a bacterial infection

  2. Concordance of HostDx Sepsis diagnostic test read-out: likelihood of viral infection [ Time Frame: 30 days after enrollment ]
    Percent agreement of HostDx Sepsis viral readout with clinical adjudication by physician 30 days after enrollment for the presence of a viral infection

  3. Concordance of HostDx Sepsis prognostic read-out (severity) with patient outcome [ Time Frame: 30 days after enrollment ]
    Percent agreement between HostDx Sepsis severity readout and patient outcome, ie mortality, severity of infection, management of patient


Biospecimen Retention:   Samples Without DNA
PAXgene RNA tubes containing whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the ED with acute respiratory infections
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Suspected Acute upper or lower respiratory infection
  3. At least two of the following:

    1. Heart rate >90 beats / minute
    2. Temperature >38 C or <36 C
    3. Respiratory rate >20 breaths / minute
    4. Systolic blood pressure <100 mmHg
    5. Altered mental status
  4. Able to provide informed consent

Exclusion Criteria:

  1. Treatment with antibiotics, antiviral agents, or antifungal agents within the past 7 days.
  2. Prisoners, mentally disabled, or unable or unwilling to give consent.
  3. Previously enrolled in the present clinical trial
  4. Concurrently enrolled in other clinical studies requiring blood draws totaling more than 35 ml within 7 days of enrollment here.

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): NCT03744741


Locations
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United States, California
Inflammatix Inc
Burlingame, California, United States, 94010
Sponsors and Collaborators
Inflammatix
University of Kentucky
Texas Tech University

Additional Information:

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Responsible Party: Inflammatix
ClinicalTrials.gov Identifier: NCT03744741     History of Changes
Other Study ID Numbers: OSCCCx-INF-02
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
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: No

Keywords provided by Inflammatix:
Respiratory Tract Infections
Host response
mRNA
diagnosis
prognosis
procalcitonin
c-reactive protein
molecular respiratory panel
adults

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases