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HostDxTM Fever in Acute Respiratory Infections

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ClinicalTrials.gov Identifier: NCT03606382
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Inflammatix

Brief Summary:

A prospective-observational study to evaluate the diagnostic performance of HostDx Fever to distinguish bacterial from viral infection.

Evaluate the diagnostic performance HostDx Fever to distinguish bacterial infection from viral infections.

Compare the diagnostic performance of HostDx Fever to that of C-reactive protein.


Condition or disease Intervention/treatment
Acute Respiratory Infection Diagnostic Test: HostDx Fever test

Detailed Description:

A prospective-observational study to evaluate the diagnostic performance of HostDx Fever to distinguish bacterial from viral infection.

Objectives:

  1. Evaluate the diagnostic performance HostDx Fever to distinguish bacterial infection from viral infections.
  2. Compare the diagnostic performance of HostDx Fever to that of C-reactive protein.

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Study Type : Observational
Estimated Enrollment : 235 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: HostDxTM Fever in the Diagnosis of Outpatients With Acute Respiratory Infections
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: HostDx Fever test
    HostDx Fever test to distinguish between viral and bacterial infections


Primary Outcome Measures :
  1. HostDx Fever to distinguish bacterial infection from viral infections [ Time Frame: 6 months ]
    Evaluate the diagnostic performance HostDx Fever to distinguish bacterial infection from viral infections.


Secondary Outcome Measures :
  1. HostDx Fever compared to C-reactive protein [ Time Frame: 6 months ]
    Compare the diagnostic performance of HostDx Fever to that of C-reactive protein


Biospecimen Retention:   Samples With DNA
Blood sample collected in PAXgene tubes


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all comers
Criteria

Inclusion Criteria:

  • Age > 1 year
  • Self-reported subjective fever within the prior 48 hours
  • A suspected acute upper or lower respiratory infection, including: sinusitis, pharyngitis, pneumonia, bronchitis, bronchiolitis, upper respiratory infection, or influenza.

Exclusion Criteria:

  • Patients who have been treated with antibiotics, antiviral agents, or antifungal agents within the past 7 days.
  • Patients that are prisoners, mentally disabled, or unable or unwilling to give consent.

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): NCT03606382


Contacts
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Contact: Oliver Liesenfeld, MD 9259639470 oliesenfeld@inflammatix.com
Contact: Claire Alexander, BSN, MBA 650-444-4476 calexander@inflammatix.com

Locations
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United States, Ohio
Licking Memorial Health Systems Recruiting
Newark, Ohio, United States, 43055
Contact: Craig Cairns, MD, PhD    220-564-4113    CCairns@lmhealth.org   
Contact: Lorei Reinhard, BS, MT    220-564-4156    LReinhard@lmhealth.org   
Sponsors and Collaborators
Inflammatix
Investigators
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Principal Investigator: Craig Cairns, MD/PhD Licking Memorial Health Systems

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Responsible Party: Inflammatix
ClinicalTrials.gov Identifier: NCT03606382     History of Changes
Other Study ID Numbers: LM-INF-01
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 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

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